losartan-potassium and Fatigue

Our objective was to determine whether, compared with control interventions, pharmacologic interventions reduce the severity of fatigue in patients with cancer or recipients of hematopoietic stem-cell transplantation (hsct).. For a systematic review, we searched medline, embase, the Cochrane Central Register of Controlled Trials, cinahl, and Psychinfo for randomized trials of systemic pharmacologic interventions for the management of fatigue in patients with cancer or recipients of hsct. Two authors independently identified studies and abstracted data. Methodologic quality was assessed using the Cochrane Risk of Bias tool. The primary outcome was fatigue severity measured using various fatigue scales. Data were synthesized using random-effects models.. In the 117 included trials (19,819 patients), the pharmacologic agents used were erythropoietins (. Erythropoietin and methylphenidate significantly reduced fatigue severity in patients with cancer and in recipients of hsct. Concerns about the safety of those agents might limit their usefulness. Future research should identify effective interventions for fatigue that have minimal adverse effects.

Topics: Central Nervous System Stimulants; Erythropoietin; Fatigue; Hematopoietic Stem Cell Transplantation; Humans; Methylphenidate; Neoplasms; Severity of Illness Index

Postpartum iron deficiency anaemia is caused by bleeding or inadequate dietary iron intake/uptake. This condition is defined by iron deficiency accompanied by a lower than normal blood haemoglobin concentration, although this can be affected by factors other than anaemia and must be interpreted in the light of any concurrent symptoms. Symptoms include fatigue, breathlessness, and dizziness. Treatment options include oral or intravenous iron, erythropoietin which stimulates red blood cell production, and substitution by red blood cell transfusion.. To assess the efficacy and harms of the available treatment modalities for women with postpartum iron deficiency anaemia.. The Cochrane Pregnancy and Childbirth Group's Trials Register (9 April 2015); the WHO International Clinical Trials Registry Portal (ICTRP), and the Latin-American and Caribbean Health Sciences Literature database (LILACS) (8 April 2015) and reference lists of retrieved studies.. We included published, unpublished and ongoing randomised controlled trials that compared a treatment for postpartum iron deficiency anaemia with placebo, no treatment, or another treatment for postpartum iron deficiency anaemia, including trials described in abstracts only. Cluster-randomised trials were eligible for inclusion. We included both open-label trials and blinded trials, regardless of who was blinded. The participants were women with a postpartum haemoglobin of 120 g per litre (g/L) or less, for which treatment was initiated within six weeks after childbirth.Non-randomised trials, quasi-randomised trials and trials using a cross-over design were excluded.. Two review authors independently assessed studies for inclusion, quality, and extracted data. We contacted study authors and pharmaceutical companies for additional information.. We included 22 randomised controlled trials (2858 women), most of which had high risk of bias in several domains. We performed 13 comparisons. Many comparisons are based on a small number of studies with small sample sizes. No analysis of our primary outcomes contained more than two studies.Intravenous iron was compared to oral iron in 10 studies (1553 women). Fatigue was reported in two studies and improved significantly favouring the intravenously treated group in one of the studies. Other anaemia symptoms were not reported. One woman died from cardiomyopathy (risk ratio (RR) 2.95; 95% confidence interval (CI) 0.12 to 71.96; two studies; one event; 374 women; low quality evidence). One woman developed arrhythmia. Both cardiac complications occurred in the intravenously treated group. Allergic reactions occurred in three women treated with intravenous iron, not statistically significant (average RR 2.78; 95% CI 0.31 to 24.92; eight studies; 1454 women; I² = 0%; low quality evidence). Gastrointestinal events were less frequent in the intravenously treated group (average RR 0.31; 95% CI 0.20 to 0.47; eight studies; 169 events; 1307 women; I² = 0%; very low quality evidence).One study evaluated red blood cell transfusion versus non-intervention. General fatigue improved significantly more in the transfusion group at three days (MD -0.80; 95% CI -1.53 to -0.07; women 388; low quality evidence), but no difference between groups was seen at six weeks. Maternal mortality was not reported.The remaining comparisons evaluated oral iron (with or without other food substances) versus placebo (three studies), intravenous iron with oral iron versus oral iron (two studies) and erythropoietin (alone or combined with iron) versus placebo or iron (seven studies). These studies did not investigate fatigue. Maternal mortality was rarely reported.. The body of evidence did not allow us to reach a clear conclusion regarding the efficacy of the interventions on postpartum iron deficiency anaemia. The quality of evidence was low.Clinical outcomes were rarely reported. Laboratory values may not be reliable indicators for efficacy, as they do not always correlate with clinical treatment effects. It remains unclear which treatment modality is most effective in alleviating symptoms of postpartum anaemia.Intravenous iron was superior regarding gastrointestinal harms, however anaphylaxis and cardiac events occurred and more data are needed to establish whether this was caused by intravenous iron.The clinical significance of some temporarily improved fatigue scores in women treated with blood transfusion is uncertain and this modest effect should be balanced against known risks, e.g. maternal mortality (not reported) and maternal immunological sensitisation, which can potentially harm future pregnancies.When comparing oral iron to placebo it remains unknown whether efficacy (relief of anaemia symptoms) outweighs the documented gastrointestinal harms.We could not draw conclusions regarding erythropoietin treatment due to lack of evidence.Further research should evaluate treatment effect through clinical outcomes, i.e. presence and severity of anaemia symptoms balanced against harms, i.e. survival and severe morbidity.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Humans; Injections, Intravenous; Iron; Postpartum Period; Puerperal Disorders; Randomized Controlled Trials as Topic

This is an updated version of the original Cochrane review published in issue 1 2008 (Minton 2008). Cancer-related fatigue (CRF) is common, under-recognised and difficult to treat. There have been studies looking at drug interventions to improve CRF but results have been conflicting depending on the population studied and outcome measures used. No previous reviews of this topic have been exhaustive or have synthesised all available data.. To assess the efficacy of drugs for the management of CRF.. We searched the Cochrane Central Register of Controlled Trials (from Issue 2 2007) MEDLINE and EMBASE from January 2007 to October 2009 and a selection of cancer journals. We searched references of identified articles and contacted authors to obtain unreported data.. Studies were included in the review if they 1) assessed drug therapy for the management of CRF compared to placebo, usual care or a non-pharmacological intervention in 2) randomised controlled trials (RCT) of 3) adult patients with a clinical diagnosis of cancer.. Two review authors independently assessed trial quality and extracted data. Meta-analyses were performed on different drug classes using continuous variable data.. Fifty studies met the inclusion criteria. Six additional studies were identified since the original review. Only 31 of these studies involving 7104 participants were judged to have used a sufficiently robust measure of fatigue and thus were deemed suitable for detailed analysis. The drugs were still analysed by class (psychostimulants; haemopoietic growth factors; antidepressants and progestational steroids). Methylphenidate showed a small but significant improvement in fatigue over placebo (Z = 2.83; P = 0.005). Since the publication of the original review increased safety concerns have been raised regarding erythropoietin and this cannot now be recommended in practice.There was a very high degree of statistical and clinical heterogeneity in the trials and the reasons for this are discussed.. There is increasing evidence that psychostimulant trials provide evidence for improvement in CRF at a clinically meaningful level. There is still a requirement for a large scale RCT of methylphenidate to confirm the preliminary results from this review. There is new safety data which indicates that the haemopoietic growth factors are associated with increased adverse outcomes. These drugs can no longer be recommended in the treatment of CRF. Readers of the first review should re-read the document in full.

Topics: Adult; Antidepressive Agents; Central Nervous System Stimulants; Darbepoetin alfa; Erythropoietin; Fatigue; Hematinics; Humans; Methylphenidate; Neoplasms; Progestins; Randomized Controlled Trials as Topic

The data and the conclusions of the Cochrane review of drug therapy for the management of cancer related fatigue (CRF) is analysed and summarized in this report. Overall, data is weakened substantially by a high degree of heterogeneity that stems primarily from the fact that fatigue is a subjective and multidimensional phenomenon Apart from erythropoietin and to some degree methylphenidate, there is no evidence that pharmacologic intervention may reduce CRF. CRF has major impact on quality of life for most patients suffering from a cancer disease. It is therefore of obvious importance to increase the focus on CRF - both in the pharmaceutical industry and in the professional-medical environment.

Topics: Antidepressive Agents, Second-Generation; Central Nervous System Stimulants; Erythropoietin; Evidence-Based Medicine; Fatigue; Hematinics; Humans; Methylphenidate; Neoplasms; Paroxetine; Progestins; Selective Serotonin Reuptake Inhibitors; Treatment Outcome

Cancer-related fatigue is an important clinical problem. It is common, distressing, and often difficult to treat. There is a role for drug treatment of cancer-related fatigue, but no consensus has been reached on which drugs are useful. This systematic review and meta-analysis aims to review the available evidence and make recommendations for practice and research.. We searched the Cochrane register of controlled trials (through the second quarter 2007), Medline (January 1, 1966, through August 1, 2007), and EMBASE (January 1, 1980, through August 1, 2007) by use of a predetermined list of search terms. Cochrane Collaboration meta-analysis review methodology was used for this study. The change in fatigue score on the instrument used in each study and other outcomes of interest (adverse events and withdrawal rates) were compared between treatment and control arms by use of the standardized mean difference (SMD) with 95% confidence intervals (CIs). All statistical tests were two-sided.. We identified 27 eligible trials of drug treatments for cancer-related fatigue (with a total of 6746 participants). The overall effect size for all drug classes was small. A meta-analysis of two studies (n = 264 patients) indicated that methylphenidate (a psychostimulant) was superior to placebo (standardized mean difference [SMD] in change in fatigue score = -0.30, 95% confidence interval [CI] = -0.54 to -0.05; P = .02) for treating cancer-related fatigue. A meta-analysis of 10 studies (n = 2226 patients) evaluating erythropoietin in anemic cancer patients who were undergoing chemotherapy indicated that erythropoietin was superior to placebo (SMD = -0.30, 95% CI = -0.46 to -0.29; P = .008). Among anemic patients (four studies with n = 964 patients), improvement in fatigue was associated with darbepoetin treatment compared with placebo treatment (SMD = -0.13, 95% CI = -0.27 to 0.00; P = .05). Progestational steroids and paroxetine were no better than placebo in the treatment of cancer-related fatigue.. There is some evidence that treatment of cancer-related fatigue with methylphenidate appears to be effective. More robust evidence indicates that treatment with hematopoietic agents appears to relieve cancer-related fatigue caused by chemotherapy-induced anemia. Further confirmatory trials are required for both observations.

Topics: Anemia; Antidepressive Agents, Second-Generation; Antineoplastic Agents; Central Nervous System Stimulants; Darbepoetin alfa; Dopamine Uptake Inhibitors; Erythropoietin; Fatigue; Hematinics; Humans; Methylphenidate; Neoplasms; Odds Ratio; Paroxetine; Progestins; Randomized Controlled Trials as Topic; Treatment Outcome

Patients with end-stage renal disease treated with maintenance hemodialysis suffer substantial impairments in health-related quality of life (HRQOL). Despite widespread efforts, there are few interventions that improve the overall well-being and quality of life of this patient population. The current review provides a description of HRQOL as an essential, yet arguably overlooked health-related domain in hemodialysis patients, and discusses interventions that have been evaluated to improve the functional status and well-being of this population, with a particular focus on therapy with recombinant human erythropoietin. We review the controversy surrounding recombinant human erythropoietin as it relates to HRQOL, and describe the delicate balance faced by renal providers who seek to reduce hemodialysis patients' morbidity and mortality while simultaneously striving to improve patients' HRQOL.

Topics: Anemia; Erythropoietin; Fatigue; Health Status; Humans; Kidney Failure, Chronic; Quality of Life; Renal Dialysis

Anemia is a decrease in circulating red blood cells that contributes to a complex group of symptoms. Anemia may be present in more than half of all patients with cancer but often is assessed, documented, prevented, and treated inadequately. Individuals with cancer are living longer, and the number of cancer treatment options provided at various points in the cancer continuum is growing; however, many treatments contribute to anemia. Because anemia can develop from multiple causes, treatment must be tailored to the underlying etiology. Cancer-related anemia can significantly affect therapeutic outcomes and patients' quality of life. Therapeutic interventions may include blood transfusions, administration of recombinant human erythropoietin, and interventions to support patient symptoms, most significantly, fatigue. Oncology nurses play a central role in risk assessment, symptom management, treatment planning, and evaluation and therefore must understand the etiology and physiology of cancer-related anemic states as well as evidence-based interventions to ensure optimal outcomes.

Topics: Algorithms; Anemia; Blood Transfusion; Causality; Cost of Illness; Decision Trees; Diagnosis, Differential; Erythropoietin; Evidence-Based Medicine; Fatigue; Hematinics; Hematocrit; Hemoglobins; Humans; Neoplasms; Nurse's Role; Nursing Assessment; Oncology Nursing; Patient Care Planning; Patient Education as Topic; Quality of Life; Risk Assessment

Anaemia and associated fatigue are common problems in patients with cancer, and fatigue is considered by patients with cancer to be their most limiting symptom. The introduction of erythropoiesis-stimulating proteins (ESPs) has greatly improved the management of anaemia; however, many European patients with cancer-related anaemia are untreated because of a lack of awareness among healthcare professionals of the benefits of anaemia treatment to patients, or because of regional differences in treatment practices. Recently, the European Organisation for Research and Treatment of Cancer (EORTC) developed the first European evidence-based guidelines for the use of ESPs in cancer-related anaemia in order to facilitate and standardize the assessment and management of the condition. These guidelines, and the implications for oncology nurses in implementing them in practice, are discussed.

Topics: Algorithms; Anemia; Decision Trees; Diagnosis, Differential; Documentation; Drug Administration Schedule; Drug Monitoring; Erythropoietin; Evidence-Based Medicine; Fatigue; Hemoglobins; Humans; Neoplasms; Nurse's Role; Nursing Assessment; Oncology Nursing; Patient Education as Topic; Patient Selection; Practice Guidelines as Topic

The database for carnitine supplements in dialysis includes no large-scale randomized trials and no registered trials. Medical practitioners prefer to make treatment decisions based on the outcome of randomized clinical trials, with appropriate controls. Furthermore, registered trials provide a further level of integrity, since trial registration avoids publication bias by ensuring that all outcomes are reported, including trials that are not completed. Positive effects reported from carnitine administration in dialysis patients include decreased erythropoietin dose, increased hematocrit, less intradialytic hypotension, and less fatigue. The evidence for carnitine effectiveness is limited to trials that are mostly open-label and that include no more than a total of 1,000 patients. An analysis of recent carnitine administrations to patients in a large dialysis practice database indicates no overall change in hemoglobin or erythropoietin dose following 6 months of carnitine administration. As outcomes of controlled trials with appropriate power to examine for the benefits of carnitine are not yet available, the dialysis practitioner cannot justify the administration of carnitine.

Topics: Anemia; Carnitine; Drug Resistance; Erythropoietin; Fatigue; Hypotension; Randomized Controlled Trials as Topic; Recombinant Proteins; Renal Dialysis; Treatment Outcome; Vitamin B Complex

In gynaecology, anaemia treatment is indicated in extremely different situations. In cancer patients, treatment with epoetin can relieve fatigue and improve quality of life. In these patients, epoetin treatment can also have a positive influence on survival through increasing the efficacy of radiotherapy and chemotherapy. Recent data are presented. In gynaecological surgery, the use of epoetin--based on results in oncology and orthopaedic surgery--makes a constructive contribution to the improvement of quality of life and during patient recovery through rapid normalisation of perioperative anaemia, thus reducing the risk of a transfusion with donated blood. Encouraging data from recent publications concerning the prevention of PRCA under epoetin treatment are presented.

Topics: Adult; Anemia; Blood Transfusion; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Pregnancy; Pregnancy Complications; Quality of Life; Recombinant Proteins; Risk Factors

Anaemia is frequently associated with lymphoma. Many causes are implicated and can sometimes be associated to each other so that the level of haemoglobin is often very low. In follicular lymphoma, the level of haemoglobin remains an independent predictive prognostic factor. Likewise, anaemia seems correlated to survival for both Hodgkin's and non-Hodgkin's lymphomas. However, therapeutic strategies to control anaemia remain somewhat unsatisfactory. Thus, recombinant erythropoietin might be an effective drug to increase the haemoglobin rate, limit the transfusional risk and improve patients' quality of life.

Topics: Anemia; Blood Transfusion; Erythropoietin; Fatigue; Hemoglobin A; Humans; Lymphoma; Prognosis; Quality of Life; Recombinant Proteins

Anemia and fatigue are frequent in lung cancer patients. Anemia is due to cancer and platinum-based chemotherapy. Anemia leads to a wide range of symptoms and affects health-related quality of life. Anemia also worsens outcome of therapy and prognosis. Efficient treatment exist: blood transfusion and recombinant erythropoietin. Early treatment of anemia is recommended as soon as diagnosis is made. But few patients receive optimal treatment. Its cost and unsolved question regarding therapeutic strategies may explain this phenomenon. This debate should not preclude correct treatment prescription. Clinical trials have to be preformed to clarify unsolved questions. As EPO administration can affect survival, this point should be of particular interest in future trials.

Topics: Anemia; Antineoplastic Agents; Blood Transfusion; Erythropoietin; Fatigue; Hemoglobin A; Humans; Lung Neoplasms; Prognosis; Recombinant Proteins

Anaemia is the most common haematological abnormality encountered by cancer patients. A large European survey of cancer patients (n = 15,367) reported that 67% had anaemia at some point during the survey, and that over 60% of these patients did not receive any treatment for their anaemia. Two other surveys (the FATIGUE surveys) showed that over 75% of cancer patients experienced fatigue at least monthly, with over 30% reporting this symptom on a daily basis. Significantly, patients regarded fatigue as having a greater negative impact on their daily lives than many other cancer- or treatment-related complications, with important emotional and mental consequences including lack of self-motivation, sadness, frustration, and mental exhaustion. Indeed, fatigue was considered so debilitating, 12% of patients felt their quality of life (QoL) was so reduced that they did not wish to continue living. Anaemia is also recognised as an independent predictor of poor prognosis in cancer patients. A systematic review evaluating survival showed a 65% overall increase in the risk of mortality in cancer patients with anaemia. Increasing physicians' awareness of the importance of effectively treating anaemia in cancer patients therefore has the potential to improve prognosis as well as QoL.

Topics: Activities of Daily Living; Anemia; Anemia, Hypochromic; Cost of Illness; Erythropoietin; Fatigue; Humans; Neoplasms; Predictive Value of Tests; Prognosis; Quality of Life; Recombinant Proteins; Risk Assessment; Risk Factors; Survival Analysis; Time Factors; Treatment Outcome

In patients with human immunodeficiency virus (HIV), anemia is a commonly encountered hematologic abnormality that has a significant impact on clinical outcomes and quality of life (QOL). This review describes the prevalence of anemia in several populations of patients with HIV and the effects of anemia on survival, morbidity, disease progression, transfusion requirements, and QOL. The prevalence of anemia in HIV disease varies considerably, ranging from 1.3% to 95%: it depends on several factors, including the stage of HIV disease, sex, age, pregnancy status, and injection-drug use as well as the definition of anemia used. In general, as HIV disease progresses, the prevalence and severity of anemia increase. Anemia is also more prevalent in HIV-positive women, children, and injection-drug users than in HIV-negative women, children, and injection-drug users. Anemia has been shown to be a statistically significant predictor of progression to the acquired immunodeficiency syndrome and is independently associated with an increased risk of death in patients with HIV. Treatment of anemia with epoetin-alpha has resulted in significantly fewer patients requiring transfusion as well as decreases in the mean number of units of blood transfused. Resolution of HIV-related anemia has been shown to improve QOL, physical functioning, energy, and fatigue in individuals with HIV. More recently, the use of highly active antiretroviral therapy has also been associated with a significant increase in hemoglobin concentrations and a decrease in the prevalence of anemia.

Topics: Activities of Daily Living; Adult; Anemia; Anti-HIV Agents; Blood Transfusion; CD4 Lymphocyte Count; Child; Comorbidity; Disease Progression; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; HIV Infections; Humans; Infant; Male; Outcome Assessment, Health Care; Pregnancy; Prevalence; Quality of Life; Recombinant Proteins; Severity of Illness Index; Substance Abuse, Intravenous; Survival Analysis

Anemia is a common comorbidity in individuals with rheumatoid arthritis (RA). In fact, anemia of the type characterized by low serum iron concentrations in conjunction with adequate iron stores is frequently associated with RA and has served as a model for anemia of chronic disease. A systematic search of the scientific literature published since January 1966 identified 19 articles that reported findings on either the prevalence of anemia in patients with RA or outcomes for patients with anemia and RA. Ten articles addressed the prevalence of anemia in patients with RA. Estimates of the prevalence of mild anemia ranged between 33% and 60%; however, the 2 studies that examined demographics in patients with RA did not identify subpopulations at particular risk for anemia. Twelve articles assessed the impact of the resolution of anemia on symptoms and quality of life (QOL) in patients with RA. For many of the parameters assessed-including swollen, painful, and tender joints, pain, muscle strength, and energy levels-a positive correlation was observed between improvement of symptoms and the resolution of anemia. In addition, 2 studies reported a significant improvement in QOL scores in patients with RA who experienced a response to treatment for anemia. These results suggest that (1) patients with RA who have anemia are likely to have more severe joint disease and (2) if the anemia is successfully treated, the joint disease will likely respond to treatment as well. Whether improvements in QOL and/or joint symptoms occur with improvement of anemia, independent of other signs of an overall response to RA therapy, remains to be determined.

Topics: Activities of Daily Living; Adult; Age Distribution; Anemia; Arthritis, Rheumatoid; Blood Transfusion; Child; Cost of Illness; Erythropoietin; Fatigue; Female; Hand Strength; Humans; Iron; Male; Outcome Assessment, Health Care; Pain; Prevalence; Quality of Life; Risk Factors; Severity of Illness Index; Sex Distribution

Iron deficiency anaemia is one of the most common disorders in the world. Also, one third of inflammatory bowel disease (IBD) patients suffer from recurrent anaemia. Anaemia has significant impact on the quality of life of affected patients. Chronic fatigue, a frequent IBD symptom itself, is commonly caused by anaemia and may debilitate patients as much as abdominal pain or diarrhoea. Common therapeutic targets are the mechanisms behind anaemia of chronic disease and iron deficiency. It is our experience that virtually all patients with IBD associated anaemia can be successfully treated with a combination of iron sucrose and erythropoietin, which then may positively affect the misled immune response in IBD.

Topics: Anemia, Iron-Deficiency; Chronic Disease; Erythropoietin; Fatigue; Folic Acid; Humans; Inflammatory Bowel Diseases; Iron; Quality of Life; Recombinant Proteins; Vitamin B 12 Deficiency

To determine the occurrence of cancer-related fatigue, the methods used to assess it, and the efficacy of the available treatments, we performed literature searches that identified English-language publications on these topics. Twenty-seven studies were identified in which the quantitative estimation of the occurrence of cancer-related fatigue was an end point. Fifty-six were judged to be relevant to the assessment of fatigue, and 10 randomized controlled clinical trials of treatments of cancer-related fatigue were retrieved. The occurrence of cancer-related fatigue was found to range from 4% to 91%, depending on the population studied and the methods of assessment. Few population-based studies and no longitudinal studies of cancer-related fatigue have been performed. The methods of fatigue assessment were highly variable. Exercise programs show promise to prevent or treat fatigue in some subsets of cancer patients, and the use of epoetin alfa for correction of anemia has been shown to ameliorate fatigue. The number of subjects in the treatment trials was small and their methodologic quality was inconsistent.

Topics: Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Evidence-Based Medicine; Exercise Therapy; Fatigue; Humans; Neoplasms; Palliative Care; Radiotherapy; Randomized Controlled Trials as Topic; Recombinant Proteins

Neuropsychiatric side effects are common with interferon-based therapy for chronic hepatitis C, and their prompt recognition and management is essential to effective patient care. Depression induced by interferon has been a significant cause of early treatment discontinuation in clinical trials. The need to monitor for and treat interferon-induced depression is well established, but whether to use antidepressants prophylactically remains controversial. Nonetheless, clinicians should maintain a low threshold for antidepressant therapy. Other significant neuropsychiatric side effects include anxiety, hypomania or mania, fatigue, and cognitive dysfunction. These can be additional sources of patient distress during interferon therapy and require appropriate intervention through patient education, psychotropic medications, support, and behavioral techniques.

Topics: Antidepressive Agents; Antimanic Agents; Antipsychotic Agents; Antiviral Agents; Anxiety; Bipolar Disorder; Clinical Trials as Topic; Cognition Disorders; Comorbidity; Depression; Erythropoietin; Fatigue; Hepatitis C, Chronic; Humans; Interferons; Mental Disorders; Psychotropic Drugs; Recombinant Proteins; Risk Factors; Substance-Related Disorders

Within the past decade, clinical trials have shown that the presence of anemia can diminish the physical status, functional abilities, and overall quality of life (QOL) of cancer patients and can negatively influence the outcome of their treatment. However, recent preclinical and clinical studies have also shown that increasing hemoglobin levels by administering recombinant human erythropoietin (rHuEPO, epoetin alfa) may ameliorate anemia and, in doing so, improve QOL and possibly result in better treatment outcomes following radiotherapy, chemotherapy, or a combination of these modalities. Several mechanisms by which rHuEPO may improve treatment outcome have been proposed, including correction of tumor hypoxia, increased sensitivity of tumor cells to radiotherapy and chemotherapy, correction of anemia and its associated symptoms (particularly fatigue), and immune-modulated effects of rHuEPO on tumor growth. Improvement of tumor oxygenation by rHuEPO could affect treatment outcome in two ways. First, correction of hypoxia results in the downregulation of hypoxia-inducible factor 1 (HIF-1), a key regulator of cellular adaptive responses to hypoxia (e.g., angiogenesis), including many pathways that are important for tumor growth and metastasis. Interruption of the HIF-1 pathway not only limits growth of the primary tumor but also reduces the potential for the development of more aggressive tumors and metastatic spread, which could ultimately improve treatment outcome. Second, within the tumor, it is the hypoxic cells that are resistant to oxygen-dependent radiotherapy and chemotherapy, and improvement in their oxygenation would increase their sensitivity to the cytotoxic effects of such treatment. Correction of anemia and its associated symptoms, particularly fatigue, can have a beneficial effect on patient QOL, and this in turn may translate into greater tolerance of radiotherapy and chemotherapy, allowing patients to receive full doses and on-schedule dosing, and thus have an increased likelihood of a therapeutic response. Lastly, results of a study using a murine model of multiple myeloma have indicated that rHuEPO may induce an immune-mediated antitumor effect. Therefore, additional research is warranted to further explore the biologic actions of rHuEPO and to determine their relevance to therapeutic outcome.

Topics: Anemia; Animals; Cell Hypoxia; Clinical Trials as Topic; Combined Modality Therapy; Disease Models, Animal; Drug Interactions; Drug Resistance, Neoplasm; Erythropoietin; Fatigue; Humans; Mice; Multiple Myeloma; Neoplasms; Quality of Life; Radiation Tolerance; Recombinant Proteins; T-Lymphocytes; Treatment Outcome

Increasingly, anemia is being recognized as a negative prognostic and predictive factor for patients undergoing chemotherapy, radiation therapy, or a combination of these treatment modalities. The results of clinical studies have shown correlations between anemia and shorter survival times in patients with a wide variety of solid tumors and hematologic malignancies, including lung, ovarian, breast, and head/neck cancers, non-Hodgkin's lymphoma, Hodgkin's disease, Waldenstrom's macroglobulinemia, and chronic lymphocytic leukemia. Also, anemia has been shown to predict treatment response in patients with ovarian, cervical, and urothelial cancers, mantle cell lymphoma, and chronic lymphocytic leukemia, as well as refractory/relapsed acute myelogenous leukemia. Based on the presumed causal relationship between anemia and poor patient outcome, several studies have examined the influence of epoetin alfa (a recombinant human erythropoietin) on outcomes in anemic patients undergoing cancer treatment. The results of these studies have been encouraging, with indications of greater locoregional tumor control and higher response rates in epoetin alfa-treated patients. Additionally, epoetin alfa therapy, by correcting anemia, has been shown to improve a patient's energy level, ability to perform daily activities, and overall quality of life (QOL). Such effects not only enhance a patient's general well-being, but may also increase their tolerance of, and willingness to undergo, full courses of their cancer therapy in a timely manner. These findings support the use of epoetin alfa to achieve gains in QOL and cancer treatment outcomes in anemic cancer patients and suggest that additional studies be conducted to further investigate the potential benefits of this agent in regard to improved outcomes.

Topics: Activities of Daily Living; Anemia; Erythropoietin; Fatigue; Hemoglobins; Humans; Neoplasms; Prognosis; Quality of Life; Recombinant Proteins; Treatment Outcome

Severe, debilitating fatigue is common in cancer patients. For many, it is the symptom that interferes most with normal routines. Virtually every modality used to treat cancer may cause fatigue, as can complications of the disease such as sleep disturbances, infections, malnutrition, hypothyroidism, and anemia. There is a significant overlap between depression and fatigue in many patients. Given the high prevalence of cancer-related fatigue, frequent assessment of patients is essential. The evaluation should include an attempt to identify reversible causes of fatigue, and screening for depression. However, many cancer patients suffer from fatigue even in the absence of any identifiable, reversible cause. For these patients, consideration can be given to suitable exercise programs, educational support and counseling, and energy conservation strategies. A trial of a stimulant medication is also reasonable. Given the heterogeneity of patients, individualized approaches are needed. For anemic patients undergoing chemotherapy, erythropoietic agents can increase hemoglobin levels. The impact of these drugs on fatigue and quality of life is uncertain. Recent reports of increased mortality and thrombotic events in cancer patients treated with epoetin require further investigation.

Topics: Antidepressive Agents; Antipsychotic Agents; Combined Modality Therapy; Counseling; Depression; Diagnosis, Differential; Drug Administration Schedule; Erythropoietin; Exercise; Fatigue; Humans; Neoplasms; Palliative Care; Randomized Controlled Trials as Topic; Self-Help Groups; Severity of Illness Index; Terminally Ill

Anemia is a common complication in patients with multiple myeloma (MM) and occurs in more than two thirds of all patients. The most frequent underlying pathophysiological mechanism is anemia of chronic disease (ACD), relative erythropoietin (EPO) deficiency (due partly to renal impairment) and myelosuppressive effects of chemotherapy, but many other factors may account for or contribute to anemia in myeloma. In patients who achieve complete remission after chemotherapy, anemia usually normalizes. Nonresponders and relapsing myeloma patients often continue to suffer from anemia. Treatment options for anemic myeloma patients include red blood cell (RBC) transfusions and recombinant human erythropoietin (rHuEPO). Red blood cell transfusions convey an immediate effect and rapidly increase the patient's hemoglobin level. Unfortunately, effects of RBC transfusions are only transient and can be associated with several risks, including infections and mild to even life-threatening immunologic reactions. rHuEPO is biologically equivalent to the human endogenous hormone EPO, and its application leads to an increase of hemoglobin levels over an extended time without the risks of blood transfusions. Several studies reported a significant improvement of erythropoiesis, reduction in transfusion need, and improved quality of life by using rHuEPO as long-term treatment of myeloma-associated anemia. Recently, an international expert panel recommended the use of rHuEPO for anemic myeloma patients where other possible causes of anemia have been eliminated.

Topics: Anemia; Cell Hypoxia; Clinical Trials as Topic; Erythropoietin; Fatigue; Humans; Models, Biological; Multiple Myeloma; Neovascularization, Pathologic; Recombinant Proteins; Transfusion Reaction; Treatment Outcome

Anemia occurs frequently in patients with cancer and is associated with impaired health-related quality of life (HRQOL). Treatment of anemia results in significant improvements in energy, activity and overall HRQOL, particularly among patients with mild-to-moderate anemia. Importantly, studies have indicated that anemia may have a negative impact on the success of radiotherapy, reducing survival and locoregional control. Recent preclinical and preliminary clinical data have also suggested that anemia may be associated with poorer outcomes following chemotherapy or surgery.. Data for review were identified and selected from searches of the literature published from January 1990 through to October 2002 using Medline, and searches of proceedings from key international oncology and hematology meetings.. A wealth of data indicate that treatment of anemia improves HRQOL in patients with cancer. Prospective studies exploring survival and/or treatment outcomes in anemic cancer patients are currently in their early stages, preventing any firm conclusions from being drawn, although they do indicate a benefit in treating anemia.. Recent studies support the use of erythropoietic agents in anemic cancer patients as a means of raising their hemoglobin levels and consequently improving their HRQOL. Randomized, controlled trials are needed to determine whether treating anemia with erythropoietic agents will improve other outcomes following therapy.

Topics: Anemia; Darbepoetin alfa; Erythropoietin; Fatigue; Health Status; Humans; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Survival; Treatment Outcome

Thirty per cent of cancer patients suffer from anemia before any treatment. This anemia is caused by haematopoiesis troubles related to cytokines production and by endogenous erythropoietin deficiency. Clinically, its symptoms, including fatigue, spoils patients'quality of life. Known as a prognostic factor for several cancers, anemia also lowers radiotherapy or chemotherapy efficiency by tumor hypoxia. Recombinant EPO restores normal haemoglobin level, quality of life and treatment efficiency.

Topics: Anemia, Aplastic; Cell Hypoxia; Erythropoietin; Fatigue; Female; Humans; Neoplasms; Oxygen Consumption; Quality of Life; Uterine Cervical Neoplasms

The National Health Service (NHS) Cancer Plan published in 2000 has a short-term focus on the most pressing problems of improving survival rates and replacing equipment. It also mentioned as a target 'improved quality of life for those affected by cancer'. Continuity of care for longer-term care programmes was seen predominantly in terms of palliative care. Recent National Institute for Clinical Excellence (NICE) reports may have reinforced this approach by focussing on the clinical and cost effectiveness of chemotherapy for late-stage cancer. The impact on local decision-makers has been that drug funds have been prioritised for use on survival-enhancing interventions, with few resources left for short and longer-term supportive care targeted primarily on improving quality of life. Within supportive care, resources are particularly limited for funding treatments such as erythropoietin for the management of cancer-related anaemia, a common and very debilitating side-effect of intensive therapy. The need for a re-focusing on supportive care is associated with cancer becoming, in many instances, a longer-term illness. The prevalence of cancer is rising markedly due to increased survival rates. However, this creates a new challenge of reducing disability and improving quality of life. In surveys, patients have rated fatigue associated with anaemia as one of the most debilitating effects of their cancer and its treatment with chemotherapy. This paper reviews the evidence demonstrating the quality of life benefits of erythropoietin, and then considers the policy constraints that have limited the adoption of this treatment within the NHS. Through co-ordinated planning there are opportunities for cancer networks and primary care trusts (PCTs) working with cancer centres to develop more support in ways which are feasible and fundable. The case is argued that PCTs and cancer networks, in implementing the Cancer Plan locally, need to integrate short- and longer-term supportive care into their cancer service development plans, and recognise the importance of anaemia management as an integral part of this. Lessons can be learnt from UK renal services where anaemia management with erythropoietin is standard practice.

Topics: Anemia; Blood Transfusion; Community Networks; Erythropoietin; Fatigue; Humans; Neoplasms; Practice Guidelines as Topic; Primary Health Care; Quality of Life; Recombinant Proteins; State Medicine; United Kingdom

To describe the management of fatigue and anemia in patients with cancer.. Published literature and clinical experience.. Anemia is a common cause of cancer-related fatigue. Epoetin alfa increases hemoglobin, decreases transfusion requirements, and improves energy and quality of life in patients with cancer-related anemia. Nonpharmacologic treatment options include exercise, nutrition optimization, and psychosocial interventions. Effective management of fatigue improves overall cancer treatment, quality of life, and functional status.. Fatigue and anemia are commonly undertreated complications of cancer and its treatment. Oncology nurses play a key role in identifying and managing these conditions.

Topics: Activities of Daily Living; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Male; Neoplasms; Nursing Assessment; Nursing Methodology Research; Oncology Nursing; Patient Care Planning; Quality of Life; Recombinant Proteins

Topics: Anemia; Antineoplastic Combined Chemotherapy Protocols; Controlled Clinical Trials as Topic; Energy Metabolism; Erythropoietin; Fatigue; Female; Humans; Male; Neoplasms; Patient Satisfaction; Prognosis; Quality of Life; Recombinant Proteins; Retrospective Studies; Treatment Outcome

This article examines the relationships between chemotherapy-induced anemia, fatigue, and psychological distress among anemic cancer patients with solid tumors. Patients participating in two randomized clinical trials evaluating the efficacy of darbepoetin alfa (Aranesp) completed a questionnaire at baseline, at the beginning of each chemotherapy cycle, and at the end of the 12-week treatment period. The questionnaire included four psychological distress outcomes: Brief Symptom Inventory (BSI) Depression and Anxiety, Functional Assessment of Cancer Therapy (FACT)-Emotional Well-Being, numeric rating scale of Overall Health, and the FACT-Fatigue subscale. Patients with a hemoglobin response of at least a 2 g/dL increase were more likely to experience meaningful improvements (at least 3 points) in FACT-Fatigue scores than nonresponders (55.0% vs 39.8%; P = .0004). Patients with meaningful improvements in FACT-Fatigue scores reported significantly greater improvements in each of the psychological outcomes relative to those without improved fatigue (P <.0001). For BSI Depression and Anxiety, the differences in mean change scores between patients with and without improved fatigue were 8.2 and 7.7, respectively. Improving the hemoglobin levels of patients undergoing chemotherapy and suffering from anemia-related fatigue has the potential to produce significant positive effects on patients' fatigue, depressive symptoms, anxiety, feelings of helplessness, and overall health.

Topics: Anemia; Antineoplastic Agents; Clinical Trials as Topic; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Humans; Male; Mental Disorders; Neoplasms; Quality of Life

Anemia, common in people with cancer, can be due to the disease itself or to the associated therapy. Fatigue, the most prevalent of all symptoms experienced by cancer patients, is the primary symptom of anemia. Caused by many factors,fatigue, regardless of etiology, has an adverse impact on health-related quality of life. Anemia is among the more treatable of those causes. Prior to the development of recombinant human erythropoietin, red blood cell transfusion was the standard treatment for cancer-related anemia. Erythropoietic agents are an effective alternative to blood transfusion: they improve hematocrit, reduce transfusion dependency, and eliminate transfusion-related risks. Although studies are mixed, most clinical trials have also suggested that erythropoietic agents have a positive impact upon cancer patients' quality of life. However, the cost of drug supply is quite high in the oncology setting, where much higher doses are required relative to the nephrology setting. Thus, although few challenge the treatment's effectiveness, cost-effectiveness remains an open question. The data collected over the years to address these questions have helped define and clarify the relationship between anemia and health-related quality of life in people with cancer. That relationship is summarized in this article.

Topics: Anemia; Clinical Trials as Topic; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life

Most of cancer patients experience anemia. It's a main cause of fatigue and it leads to a decrease of the quality of life. It may have an impact on prognostic too, mainly when radiotherapy is concerned. Apart from etiologic treatments, anemia can be treated with transfusion and/or erythropoietin. Their respective pros and cons are discussed. There are few guidelines available on this topic and an algorithm of decision is proposed.

Topics: Anemia; Blood Transfusion; Erythrocyte Transfusion; Erythropoietin; Fatigue; Humans; Practice Guidelines as Topic; Quality of Life

Anaemia is a common occurrence in patients with cancer and contributes to the clinical symptomatology and reduced quality of life (QOL) seen in cancer patients. Many aspects of reduced QOL, including fatigue, are known to be associated with suboptimally low levels of haemoglobin. Even mild-to-moderate anaemia adversely affects patient-reported QOL parameters. Red blood cell transfusions are associated with many real and perceived risks, inconveniences, costs, and only temporary benefits. Recombinant human erythropoietin (rHuEPO) is an effective therapy to increase haemoglobin values in over half of anaemic cancer patients receiving concurrent chemotherapy. These increased haemoglobin values are closely correlated with improvements in QOL. Despite these objectively defined benefits, less than 50% of anaemic patients undergoing cytotoxic chemotherapy receive rHuEPO, in contrast to patients with chronic renal failure on dialysis, where anaemia is universally and aggressively treated to more optimal haemoglobin values. However, there are several barriers that may limit more widespread use of rHuEPO. These include inconvenience associated with frequent dosing; failure of a large proportion (40 to 50%) of patients to respond; relatively slow time to response; absence of reliable early indicators of response; and current lack of rigorous pharmacoeconomic data demonstrating cost-effectiveness. Darbepoetin alfa is a novel erythropoiesis stimulating protein (NESP) that is biochemically distinct from rHuEPO, and which has been proven to stimulate red blood cell production. The molecule has a 3-fold longer half-life and increased biological activity that will allow less frequent dosing, facilitating improved management of the anaemia of cancer. With this new option for therapy, further avenues of investigation should lead to renewed interest in the clinical benefits of optimal haemoglobin levels for patients with cancer.

Topics: Anemia; Antineoplastic Agents; Case Management; Clinical Trials as Topic; Darbepoetin alfa; Erythrocyte Transfusion; Erythropoietin; Fatigue; Forecasting; Health Care Costs; Humans; Hypoxia; Incidence; Kidney Failure, Chronic; Multicenter Studies as Topic; Neoplasms; Quality of Life; Radiation Tolerance; Recombinant Proteins; Treatment Outcome

Hysterectomy is the second-most-common surgical procedure among premenopausal women. The conditions that lead to the need for a hysterectomy often are accompanied by chronic blood loss that can lead to anemia. Moreover, hysterectomy and myomectomy may result in significant blood loss, which exacerbates the anemia. The presence of fatigue associated with anemia has a substantially negative impact on quality of life and the ability to perform activities of daily living. Options for alleviating perioperative anemia include minimizing surgical blood loss, blood transfusion, supplementation with hematinics, such as iron and folic acid, and treatment with recombinant human erythropoietin. Treating preoperative anemia is expected to help correct anemia prior to surgery and may have a positive impact on anemia-related symptoms and surgical outcomes.

Topics: Anemia; Blood Loss, Surgical; Blood Transfusion; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Gonadotropin-Releasing Hormone; Gonadotropins; Hematinics; Hematocrit; Humans; Hysterectomy; Preoperative Care; Recombinant Proteins

Recombinant human erythropoietin (r-HuEPO, epoetin alfa) is used for treatment of anemia associated with chemotherapy for non-myeloid malignancies, chronic renal failure and zidovudine treatment in patients infected with the human immunodeficiency virus and for anemic patients undergoing elective, noncardiac, nonvascular surgery. Epoetin alfa has been shown to safely increase preoperative hemoglobin (Hb) levels in anemic patients undergoing elective noncardiac, nonvascular surgery and is more effective than preoperative autologous blood donation in reducing the need for perioperative blood transfusions in orthopedic surgery patients. Epoetin alfa was shown to significantly increase Hb levels and decrease transfusion requirements in gynecologic cancer patients undergoing chemotherapy. A once-weekly regimen of 40,000 IU per dose was effective in these patients. In addition to decreasing transfusion requirements and increasing Hb, epoetin alfa for relieving anemia-related fatigue and improving quality of life was demonstrated in clinical trials in anemic cancer patients receiving chemotherapy. With regard to quality of life in orthopedic surgery patients, a novel instrument to measure the effect of Hb management on postoperative recuperative power (i.e., vigor, functional ability) has been validated and may prove to be useful in optimizing rehabilitation and discharge planning. Extensive clinical experience with epoetin alfa in anemic patients undergoing major elective orthopedic surgery or those with gynecologic cancer provides a strong basis for its use in gynecologic surgery.

Topics: Anemia; Blood Transfusion; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Gynecologic Surgical Procedures; Hematinics; Hemoglobins; Humans; Neoplasms; Orthopedics; Quality of Life; Recombinant Proteins; Safety; Treatment Outcome

Perioperative anemia is a common complication of major surgery that may lead to prolonged and debilitating fatigue and reduction in health-related quality of life (QOL). Treatment with recombinant human erythropoietin (r-HuEPO, epoetin alfa) has been shown to increase perioperative hemoglobin (Hb) and hematocrit (HCT) levels, thereby facilitating postoperative recovery in orthopedic surgery patients. Treatment with epoetin alfa has also been shown to increase Hb and HCT levels and improve QOL in anemic cancer patients undergoing chemotherapy. The clinical and QOL benefit of using epoetin alfa in these patient populations provides the rationale for its use in patients undergoing gynecologic surgery. Because persistent fatigue is the most common complaint of patients following hysterectomy, the use of epoetin alfa should be considered to preoperatively correct anemia in this patient population. Research has been initiated to increase our understanding of the role of epoetin alfa in treating anemic patients (Hb levels < or = 13 g/dL) undergoing surgery for benign gynecologic disease, especially as it relates to postoperative QOL. Future studies should investigate the use of epoetin alfa in patients with gynecologic cancers. These studies should confirm the role of epoetin alfa in combination with iron supplementation to improve perioperative Hb/HCT levels and overall QOL in patients undergoing gynecologic surgery.

Topics: Anemia; Elective Surgical Procedures; Epoetin Alfa; Erythropoietin; Fatigue; Female; Forecasting; Gynecologic Surgical Procedures; Hematinics; Humans; Perioperative Care; Quality of Life; Recombinant Proteins; Safety; Treatment Outcome

Doping consists in the use of artificial means or substances with the unique aim of improving performance despite adverse effects on health. Amphetamines stimulate the central nervous system by increasing motivation and vigilance. Often consumed in association with analgesics, they increase the fatigue threshold during prolonged or repeated exercise. Addiction and dependency to these substances are extremely rapid. Side-effects include insomnia, exhaustion, violence and can lead to serious heart diseases. By enhancing capacity for intensive training, anabolic steroids improve strength, alertness and speed. This action is often further strengthened by the use of growth hormones DHEA and IGF-1. Extremely high dosage is used and is in no way comparable with natural secretions or those necessary to re-balance an exhausted glandular system. During prolonged endurance exercise, doping aims at improving the circulation of oxygen in the blood and thus its availability to the muscles. Firstly, the blood haemoglobin concentration was increased by blood transfusions. At present the production of red blood cells is stimulated by repeated injections of exogenous erythropoietin. The extreme viscosity of the blood leads to a risk of vascular thromboses and high blood pressure and accentuates greatly and sometimes even fatally the possibility of brachycardia which is common with sportsmen.

Topics: Amphetamines; Anabolic Agents; Bradycardia; Cardiovascular Diseases; Doping in Sports; Erythropoietin; Fatigue; Growth Hormone; Humans; Hypertension; Thrombosis

The use of hematopoietic growth factors has increased rapidly during the last decade. Among the growth factors available, erythropoietin (EPO) was the first growth factor to be used clinically. To date, EPO has shown activity in the treatment of the tumor-associated anemia and for correction of tumor hypoxia, however, when compared with transfusion of erythrocytes EPO treatment did not significantly prolong survival in cancer patients in any published study so far. Recently, novel extramedullary EPO receptors have been identified leading to a better understanding of the molecular mechanisms of action of EPO. Results from these experiments and from several clinical studies suggest that EPO treatment may be beneficial for patients with (chronic) infections (HIV, inflammatory bowel disease, septic episodes) and for treatment of the fatigue syndrome following cancer chemotherapy. In addition, EPO may also improve stem cell engraftment following high-dose chemotherapy and can increase survival rates of patients with aplastic anemia and myelodysplastic syndrome. Currently, new EPO derivatives, synthetic fusion proteins and gene therapeutic studies are under clinical investigation suggesting that the EPO-induced effects may be increased significantly by these agents in the future.

Topics: Anemia, Aplastic; Chronic Disease; Erythropoietin; Fatigue; Genetic Therapy; Hematopoietic Stem Cell Mobilization; Hematopoietic Stem Cell Transplantation; HIV Infections; Humans; Infections; Myelodysplastic Syndromes; Receptors, Erythropoietin; Recombinant Proteins

Exhaustion and tiredness are frequent symptoms in cancer patients. They are caused by the tumour itself and by application of chemotherapy, surgery, radiation or cytokine treatment. Exhaustion and tiredness are not a consequence of lacking sleep or exaggerated physical or mental labour, but are due to several other factors: Anemia, tumour cachexia, toxicity of chemo- and radiation treatment probably are the most decisive factors for the development of exhaustion and tiredness. As both were taken as inevitable side-effects of cancer and cancer treatment in the past, only little attention has been paid to exhaustion and tiredness and limited research has been done. Among several validated questionnaires measuring quality of life in tumour patients the FACT-An (Functional Assessment of Cancer Treatment--Anemia) and EORTC QLQ-C30 questionnaire are the most well-known for identifying exhaustion and tiredness. Nevertheless, until today there is no mere exhaustion scale exclusively dealing with the problem of exhaustion and tiredness. According to the 10th revision of the International Classification of Diseases (ICD) exhaustion and tiredness are subsumed under the diagnosis of tumour fatigue. In contrast to tumour fatigue, which comprises physical, mental and emotional dimensions, exhaustion and tiredness primarily refer to physical symptoms: Lacking resilience for activities of daily life, day sleepiness and nocturnal insomnia as well as restricted power of concentration are the mainstays of exhaustion and tiredness. However, regarding lacking interests, diminished energy and reduced mental capacity, exhaustion and fatigue partly overlap. From a therapeutic point of view behavioural interventions and drug therapy have successfully been tried. Beside physical exercise and psychostimulants application of Erythropoietin represents an innovative treatment of exhaustion and tiredness.

Topics: Clinical Trials as Topic; Combined Modality Therapy; Erythropoietin; Fatigue; Humans; Leukemia; Neoplasms; Palliative Care; Quality of Life; Recombinant Proteins

Topics: Adult; Anemia; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Recombinant Proteins

One of the goals of the proposed National Comprehensive Cancer Network Practice Guidelines for Cancer-Related Fatigue is outlining a systematic approach to the evaluation, intervention, and assessment of outcome in the treatment of fatigue. Anemia has been characterized as a major contributor to fatigue, and a review of patients receiving cancer therapy showed that the majority developed anemia. The current data support the value of returning hemoglobin levels to the normal range in terms of maximizing improvements in quality of life related to anemia. The potential impact of anemia in terms of treatment outcome is under investigation.

Topics: Anemia; Clinical Trials as Topic; Erythropoietin; Fatigue; Female; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Risk Factors

To compare usual care with a home-based individualized exercise program (HBIEP) in patients receiving intensive treatment for multiple myeloma (MM)and epoetin alfa therapy.. Randomized trial with repeated measures of two groups (one experimental and one control) and an approximate 15-week experimental period.. Outpatient setting of the Myeloma Institute for Research and Therapy at the Rockfellow Cancer Center at the University of Arkansas for Medical Sciences.. 187 patients with newly diagnosed MM enrolled in a separate study evaluating effectiveness of the Total Therapy regimen, with or without thalidomide.. Measurements included the Profile of Mood States fatigue scale, Functional Assessment of Cancer Therapy-Fatigue, ActiGraph® recordings, 6-Minute Walk Test, and hemoglobin levels at baseline and before and after stem cell collection. Descriptive statistics were used to compare demographics and treatment effects, and repeated measures analysis of variance was used to determine effects of HBIEP.. Fatigue, nighttime sleep, performance (aerobic capacity) as dependent or outcome measures, and HBIEP combining strength building and aerobic exercise as the independent variable.. Both groups were equivalent for age, gender, race, receipt of thalidomide, hemoglobin levels, and type of treatment regimen for MM. No statistically significant differences existed among the experimental and control groups for fatigue, sleep, or performance (aerobic capacity). Statistically significant differences (p < 0.05) were found in each of the study outcomes for all patients as treatment progressed and patients experienced more fatigue and poorer nighttime sleep and performance (aerobic capacity).. The effect of exercise seemed to be minimal on decreasing fatigue, improving sleep, and improving performance (aerobic capacity).. Exercise is safe and has physiologic benefits for patients undergoing MM treatment; exercise combined with epoetin alfa helped alleviate anemia.

Topics: Adult; Affect; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Epoetin Alfa; Erythropoietin; Exercise; Fatigue; Female; Home Care Services; Humans; Male; Middle Aged; Models, Biological; Motor Activity; Multiple Myeloma; Muscular Atrophy; Peripheral Blood Stem Cell Transplantation; Polysomnography; Recombinant Proteins; Resistance Training; Sleep Disorders, Intrinsic; Thalidomide; Walking

Fatigue is frequent in cancer patients undergoing chemotherapy. Erythropoietins (EPO) have shown well-documented effects on these patients, and administered in pharmacological doses, may reduce the need for transfusion of blood cells and improve quality of life (QoL). An explorative, descriptive, non-randomised intervention study using semi-structured interviews was conducted with the aim to gain an insight into the effects and experiences associated with EPO treatment in combination with a structured 6-week physical exercise intervention. Sixteen cancer patients with evidence of disease, who had received at least one cycle chemotherapy, participated. Participants received 500 μg Darbepoetin Alfa (DA) every 3 weeks during the intervention. Four typologies of patients were identified with regard to DA effects. The interviews revealed that eleven patients experienced some kind of immediate improvement in cognitive and emotional functioning, and subjective daily well-being. Furthermore physical improvement and changes in QoL outcomes showed no significant differences between the study group and a reference group. A significant increase in the hemoglobin concentration (7.14-7.87 mmol/L, P<0.05) was found in the study group. The future use of EPO in cancer patients is hampered by the reported negative influence of EPO on the prognosis in some diagnoses and should be based on randomized studies.

Topics: Adolescent; Adult; Aged; Darbepoetin alfa; Drug-Related Side Effects and Adverse Reactions; Erythropoietin; Exercise Therapy; Fatigue; Female; Hematinics; Humans; Male; Middle Aged; Neoplasms; Treatment Outcome; Young Adult

The relationship between darbepoetin alfa and fatigue in chemotherapy-induced anemia (CIA) patients is complex because of patients receiving transfusions and the mediating effect of hemoglobin. Latent growth models (LGMs) were used to examine simultaneously relationships among drug exposure, fatigue outcomes, covariates, and mediating factors.. Data from four CIA studies (AMG 20010145: small cell lung cancer, n=547; AMG 980297: lung cancer, n=288; AMG 20000161: lymphoproliferative malignancies, n=339; AMG 20030232: non-myeloid malignancies, n=320) were analyzed separately. Patients reported fatigue using the FACT-Fatigue. The effect of darbepoetin alfa on FACT-F changes mediated through hemoglobin changes was examined with LGMs controlling for transfusions, age, sex, baseline ECOG performance status, and health status (EQ-5D VAS). Model fit was assessed using multiple indices including the comparative fit index (CFI).. Darbepoetin alfa increased hemoglobin levels which were associated with decreases in fatigue. Increases in hemoglobin were statistically significantly (p<0.05) related to decreases in fatigue in the studies (AMG 20030145: beta=0.28; AMG 980297: beta=0.46; AMG 20000161: beta=0.59; and AMG 20030232: beta=0.39). Darbepoetin alfa statistically significantly increased hemoglobin (AMG 20010145:beta=0.50, AMG 980297:beta=0.53, AMG 20000161:beta=0.47, and AMG 20030232:beta=0.30) while controlling for covariates. Model fit was acceptable (CFI> or =0.89) in all studies.. Results indicate LGMs may be a valuable statistical method for modeling complex relationships among clinical and patient reported outcomes. A statistically significant effect of darbepoetin alfa on fatigue change through hemoglobin change occurred across four studies, after modeling the effects of transfusions, age, sex, EQ-5D VAS and ECOG.

Topics: Anemia; Antineoplastic Agents; Area Under Curve; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Health Status Indicators; Hematinics; Hemoglobins; Humans; Likelihood Functions; Male; Middle Aged; Models, Statistical; Multivariate Analysis; Neoplasms; Regression Analysis; Statistics as Topic

To determine whether epoetin alfa reduces anemia-related fatigue, improves other aspects of health-related patient-recorded outcomes (PROs), reduces the number of RBC transfusions, and has an impact on freedom from treatment failure (FFTF) and overall survival (OS) in patients with advanced-stage Hodgkin's lymphoma (HL).. The prospectively randomized HD15EPO study performed by the German Hodgkin Study Group investigated epoetin alfa administered at doses of 40,000 U weekly during and after chemotherapy (six to eight cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone [BEACOPP]) in a double-blind, placebo-controlled setting. The study accrued 1,379 patients, of whom 1,328 were assessable for safety, 1,303 were assessable for clinical outcome, and 930 were assessable for PROs.. PROs were not different in patients receiving placebo or epoetin alfa, both after the end of chemotherapy and 6 months thereafter. There was no difference between patients treated with epoetin alfa or placebo with respect to FFTF and OS. There were also no differences in the numbers of deaths, progressions, relapses, and thromboembolic events. The median number of RBC transfusions was reduced from four per patient in the placebo group to two per patient in the epoetin alfa group (P < .001), with 27.4% of patients needing no RBC transfusion in the placebo group compared with 36.7% of patients in the epoetin alfa group (P < .001).. Epoetin alfa administered at 40,000 U weekly parallel to BEACOPP chemotherapy was safe in patients with advanced-stage HL and reduced the number of RBC transfusions but had no impact on fatigue and other PRO domains.

Topics: Adolescent; Adult; Anemia; Antineoplastic Combined Chemotherapy Protocols; Bleomycin; Cyclophosphamide; Double-Blind Method; Doxorubicin; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Etoposide; Fatigue; Female; Germany; Hematinics; Hodgkin Disease; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Neoplasm Staging; Prednisone; Procarbazine; Proportional Hazards Models; Prospective Studies; Recombinant Proteins; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vincristine; Young Adult

The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial, and predictors of change in quality of life in endstage renal disease have not been well characterized.. Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were randomly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks, using epoetin_alfa as primary therapy. Patients and attending physicians were masked to treatment assignment. Quality of life, a secondary outcome, was prospectively recorded using the Kidney Disease Quality of Life (KDQoL) questionnaire at weeks 0, 24, 36, 48, 60, 72, 84, and 96, with prespecified outcomes being fatigue and quality of social interaction.. The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr. Mortality was low, reflecting the relatively healthy group enrolled. Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups. Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time (P = 0.007) compared with change in the low-target group. Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains.. In relatively healthy hemodialysis patients, normal hemoglobin targets may have beneficial effects on fatigue. Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements.

Topics: Anemia; Body Mass Index; Canada; Epoetin Alfa; Erythropoietin; Europe; Fatigue; Female; Hematinics; Hemoglobins; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Quality of Life; Recombinant Proteins; Renal Dialysis; Social Behavior; Surveys and Questionnaires; Time Factors; Treatment Outcome

To evaluate the effect of epoetin alfa on local disease-free survival (DFS), overall survival (OS), and cancer treatment-related anemia and fatigue in patients with head and neck cancer receiving radical radiotherapy with curative intent.. Patients (N = 301) with hemoglobin (Hb) less than 15 g/dL were randomly assigned in a ratio of 1:1 to receive radiotherapy plus epoetin alfa (10,000 U subcutaneously [SC] three times weekly if baseline Hb was < 12.5 g/dL; 4,000 U SC three times weekly if baseline Hb > or = 12.5 g/dL) or radiotherapy alone. Hb levels were monitored weekly. The primary end point was local DFS, defined as the time from random assignment to local disease recurrence or death. Secondary efficacy end points included OS, local tumor response, and local tumor control. Patients were followed at 1, 4, 8, and 12 weeks postradiotherapy and annually for 5 years. Cancer treatment-related anemia and fatigue were evaluated with the Functional Assessment of Cancer Therapy-Anemia and Functional Assessment of Cancer Therapy-Head and Neck. Adverse events were recorded up to 12 weeks postradiotherapy.. Hb levels increased from baseline with epoetin alfa. The median duration of local DFS was not statistically different between groups (observation, 35.42 months; epoetin alfa, 31.47 months; hazard ratio, 1.04; 95% CI, 0.77 to 1.41). Groups did not significantly differ in DFS, OS, tumor outcomes, or cancer treatment-related anemia or fatigue. No new or unexpected adverse events were observed.. Addition of epoetin alfa to radical radiotherapy did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in patients with head and neck cancer.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Carcinoma, Squamous Cell; Disease Progression; Disease-Free Survival; Epoetin Alfa; Erythropoietin; Fatigue; Female; Head and Neck Neoplasms; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Recombinant Proteins; Survival Rate

Patients with myelodysplastic syndromes (MDS) often develop anaemia resulting in frequent transfusions and fatigue. Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia. This single-arm, phase 2 study examined the efficacy of darbepoetin alfa 500 microg every 3 weeks (Q3W) for treating anaemia in low-risk MDS patients (after 6 weeks, poor responders received darbepoetin alfa 500 microg every 2 weeks). The primary end-point was the incidence of erythroid responses (International Working Group criteria) after 13 weeks of therapy. Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters. Analyses were stratified by the patient's previous ESA therapy status [ESA-naïve (n = 144) vs. prior ESA-treated (n = 62)]. After 13 weeks of therapy, 49% of ESA-naïve patients and 26% of prior ESA-treated patients achieved a major erythroid response. After 53/55 weeks, 59% of ESA-naïve patients and 34% of prior ESA-treated patients achieved a major erythroid response; 82% of ESA-naïve patients and 55% of prior ESA-treated patients achieved target haemoglobin of 110 g/l. Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported. In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

Topics: Aged; Aged, 80 and over; Anemia; Blood Transfusion; Darbepoetin alfa; Disease Progression; Drug Administration Schedule; Erythropoiesis; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myelodysplastic Syndromes; Time Factors; Treatment Outcome

This study was conducted to develop a brief measure of fatigue and functional impact in cancer patients with anemia.. Data were obtained from a multisite, phase 2 study of darbepoetin-alpha (n = 1,558). Eligible patients were >or=18 years with nonmyeloid malignancies and anemia (hemoglobin

Topics: Adult; Aged; Aged, 80 and over; Anemia; Clinical Trials, Phase II as Topic; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Male; Middle Aged; Multicenter Studies as Topic; Neoplasms; Predictive Value of Tests; Quality of Life; Sickness Impact Profile; Surveys and Questionnaires

Anaemia is common in cancer patients treated with chemotherapy. Darbepoetin alfa (DA) is the only erythropoiesis-stimulating protein approved for administration at weekly and every-three-week intervals in cancer patients receiving chemotherapy. This article investigates the effectiveness, tolerability and effect on fatigue of DA.. Prospective, observational study performed in 30 Spanish centres. Eligible patients were > or = 18 years of age, anaemic (haemoglobin [Hb] < or = 11 g/dL), with non-myeloid malignancies, receiving chemotherapy. DA (150 mug) was administered weekly for a maximum of 16 weeks (dosage doubled if Hb increased < 1 g/dL after 4 weeks).. Haematopoietic response (Hb increase > or = 2 g/dL or Hb > or = 12 g/dL in the absence of transfusions in the previous 28 days), transfusion required between Weeks 5 and 16 and fatigue measured by the Fatigue subscale of the Functional Assessment of Cancer Therapy.. 293 adults were recruited (56.4% women), with lymphoproliferative malignancies (44.3%) or solid tumours (55.7%). Baseline Hb was 9-11 g/dL in 83.7% of patients. Sixty-four per cent (95% CI: 58.1-69.4%) had a haematopoietic response and 12% required transfusions. After adjusting for performance status, concomitant diseases and chemotherapy type, an increase in Hb level was significantly associated with an improvement in Fatigue subscale (+1.9 points per 1 g/dL). Only 2% of patients had treatment-related adverse events: thromboembolic pulmonary disease (0.3%); hypersensitivity reaction (0.3%); local pain following DA administration (0.3%); insomnia (0.3%); thrombocytosis (0.3%) and deep vein thrombosis (0.3%).. Fixed-dose DA administered once weekly seems to be an effective, well-tolerated treatment for chemotherapy-induced anaemia in patients with non-myeloid malignancies, and there is an indication of a possible benefit on fatigue in the clinical practice.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Darbepoetin alfa; Erythropoiesis; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Time Factors

Epoetin-beta is extremely useful as a drug for treating anemia in hemodialysis (HD) patients and is widely used for that purpose. The aim of this study was to determine whether once-weekly intravenous administration of epoetin-beta is as effective in maintaining hemoglobin (Hb) concentration as the same weekly dose administered 2 or 3 times per week as maintenance treatment of anemia in HD patients. The subjects were stable HD patients who had been receiving HD for at least 12 months. Using a fixed weekly dose of 3000 or 6000 IU of epoetin-beta, this study evaluated maintenance of improvement of anemia by comparing Hb concentration in the study period (once-weekly) with Hb concentration in the prestudy period (2 or 3 times per week). Of the 112 patients treated with epoetin-beta, 111 patients (full analysis set; 3000 IU, 52 patients; 6000 IU, 59 patients) were evaluated, after excluding one patient whose dose was changed immediately before study initiation. The change in the Hb concentration was maintained within +/-1.5 g/dL in 89.2% of patients (3000 IU, 88.5%; 6000 IU, 89.8%). The mean Hb concentration was 10.42 +/- 0.73 g/dL at study initiation and 10.14 +/- 1.00 g/dL at study completion. Adverse reactions occurred in 9.8% of patients (11 out of 112 patients). The main adverse reactions were malaise and increased blood pressure. Once-weekly intravenous administration of epoetin-beta is useful as maintenance treatment of anemia in HD patients and may be a treatment option.

Topics: Aged; Anemia; Blood Pressure; Dose-Response Relationship, Drug; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Prospective Studies; Recombinant Proteins; Renal Dialysis

To determine the effect of aerobic and strength resistance training and epoetin alfa (EPO) therapy on transfusions, stem cell collections, transplantation recovery, and multiple myeloma treatment response.. Randomized clinical trial.. A myeloma research and therapy center in the south central United States.. 135 patients with multiple myeloma, 120 evaluable.. Random assignment to exercise or usual care groups. All patients received EPO based on an algorithm. Aerobic capacity, using the six-minute walk test, was assessed prior to induction chemotherapy, prior to stem cell mobilization, and following stem cell collection for all patients and before and after transplantation for patients continuing in the study. Data analysis included analysis of variance to compare other outcome variables by groups.. Number of red blood cell and platelet transfusions during transplantation, number of attempts at and total number of days of stem cell collection, time to recovery after transplantation, and response to intensive therapy for multiple myeloma.. Recovery and treatment response were not significantly different between groups after transplantation. The exercise group had significantly fewer red blood cell transfusions and fewer attempts at stem cell collection. Serious adverse events were similar in each group.. Exercise with prophylactic EPO therapy reduces the number of RBC transfusions and attempts at stem cell collection for patients receiving intensive treatment for multiple myeloma.. Exercise is safe and has many physiologic benefits for patients receiving multiple myeloma treatment.

Topics: Adult; Aged; Analysis of Variance; Anemia; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Combined Modality Therapy; Cyclophosphamide; Dexamethasone; Doxorubicin; Epoetin Alfa; Erythropoietin; Etoposide; Exercise Test; Exercise Therapy; Fatigue; Female; Hematinics; Humans; Male; Middle Aged; Multiple Myeloma; Nurse's Role; Nursing Evaluation Research; Oncology Nursing; Peripheral Blood Stem Cell Transplantation; Recombinant Proteins; Treatment Outcome; Vincristine

Chemotherapy-induced anemia (CIA) may substantially impact the health-related quality of life (HRQoL) of older cancer patients. This exploratory analysis evaluated the effect of darbepoetin alfa administered as a fixed dose (300 microg) every 3 weeks (Q3W) on hematologic outcomes, HRQoL, and safety in older (> or =65 years old) versus younger (<65 years old) patients with CIA (hemoglobin <11 g/dl). Patients were categorized by age at screening: <65, > or =65 to <70, > or =70 to <75, > or =75 to <80, and > or =80 years old. Patients who received at least one dose of darbepoetin alfa were included in the analysis; of 1,493 patients, 724 were > or =65 years old. Age did not appear to influence hematologic outcomes after treatment with darbepoetin alfa; in all age categories, similar percentages of patients (78%-80%) achieved the target hemoglobin in approximately the same time (4-5 weeks). Also, the percentage of patients in each age category who received RBC transfusions was reduced from 10%-13% in month 1 to 2%-4% in month 4. Although younger patients reported the greatest improvement in HRQoL scores, approximately one half in each older age category reported clinically significant improvement in fatigue, and improvement in the Energy and Overall Health Assessment and Work Productivity and Activity Impairment scales. There were no treatment-related deaths. Treatment-related thromboembolic events were reported by <1% of patients <65 years old and <1% of patients > or =65 to <70 and > or =70 to <75 years old. Darbepoetin alfa Q3W appeared well tolerated and effective for treating older patients with CIA.

Topics: Activities of Daily Living; Adult; Age Factors; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Biomarkers; Darbepoetin alfa; Drug Administration Schedule; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Follow-Up Studies; Hematinics; Hemoglobins; Humans; Karnofsky Performance Status; Male; Middle Aged; Neoplasms; Quality of Life; Research Design; Surveys and Questionnaires; Treatment Outcome

Patients with cancer who are receiving chemotherapy often experience chemotherapy-induced anemia (CIA), which is associated with symptoms that reduce quality of life. The M. D. Anderson Symptom Inventory (MDASI) is a brief, self-rating assessment scale that measures the severity of core symptoms and symptom interference with function. The current study used the MDASI to prospectively assess the correlation between hemoglobin and self-perceived cancer-related symptoms in a large patient population with CIA who were receiving darbepoetin-alpha at a dose of 200 mug every 2 weeks.. Eligible patients enrolled in this multicenter, open-label study were age > or =18 years, had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic (hemoglobin < or = 11 g/dL). Hemoglobin was measured every 2 weeks; the MDASI was administered weekly. For hemoglobin-based endpoints, patients were stratified by baseline hemoglobin (< 10 g/dL or > or =10 g/dL).. Of 2422 enrolled patients, 2401 received > or =1 dose of darbepoetin-alpha. Eighty percent of patients (95% confidence limit, 78-82 patients) achieved target hemoglobin levels (> or =11 g/dL) during the study. Patients with a baseline hemoglobin < 10 g/dL had a greater increase in hemoglobin, took longer to achieve the target hemoglobin, and received more red blood cell transfusions than patients with a baseline hemoglobin > or =10 g/dL. The percentage of patients with moderate to severe MDASI scores (> or =5 points) for fatigue, distress, loss of appetite, disturbed sleep, and interference with function was reduced during the study. Improvement in symptom burden was associated with an increase in hemoglobin concentration.. Treatment with darbepoetin-alpha at a dose of 200 mug every 2 weeks is associated with improvement in symptom burden as measured by the MDASI, a simple tool that may improve symptom management for cancer patients with CIA.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Hypochromic; Antineoplastic Combined Chemotherapy Protocols; Cost of Illness; Darbepoetin alfa; Dose-Response Relationship, Drug; Drug Administration Schedule; Erythropoietin; Fatigue; Female; Hematinics; Humans; Male; Middle Aged; Surveys and Questionnaires; Treatment Outcome

To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia.. An exploratory, 32 week, randomized, double-blind, crossover treatment trial.. Sixty-two community-dwelling individuals aged 65 and older with chronic anemia (Hb < or =11.5 g/dL).. Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II).. Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test.. Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age+/-standard deviation of 76.1+/-7.2. Mean baseline Hb was 10.5+/-0.9 g/dL (7.3-11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo (P<.001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P<.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated.. In this trial involving predominantly older African-American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.

Topics: Aged; Anemia; Chicago; Comorbidity; Cross-Over Studies; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Mobility Limitation; Quality of Life; Recombinant Proteins; Treatment Outcome

To evaluate the effect of epoetin alfa on quality of life (QOL) in patients with solid tumors and mild-to-moderate anemia receiving platinum-based chemotherapy relative to population norms.. In the original study, patients (n = 316) with hemoglobin (Hb) levels < or =12.1 g/dl were randomized 2:1 to receive either epoetin alfa at a dose of 10,000 U thrice weekly s.c. or best supportive care (BSC) to compare the effects on transfusion use, hematologic response, and QOL (measured by the Functional Assessment of Cancer Therapy-Anemia [FACT-An]and Cancer Linear Analogue Scale [CLAS]). The QOL data from this previously reported trial were reanalyzed here relative to population norms.. Mean baseline QOL scores were similar between groups. At study completion, mean CLAS, FACT-An, FACT-An Anemia subscale, and FACT-An Fatigue subscale scores were significantly higher for patients given epoetin alfa than for those treated with BSC. Compared with population norms, both groups had impaired QOL at baseline. Differences in mean QOL change scores from baseline to study end for epoetin alfa versus BSC were 3.17 points for the FACT-General Total, 9.90 for the FACT-An Fatigue subscale, and 7.30 for the FACT-An Anemia subscale. This was equivalent to corrections in QOL deficits attributable to epoetin alfa of 97.3%, 40.7%, and 38.0% for the FACT-General Total, FACT-An Fatigue, and FACT-An Anemia subscale scores, respectively, versus BSC. A somewhat greater QOL benefit was observed for the FACT-An Fatigue and FACT-An Anemia subscales in the subset of patients with baseline Hb levels >10.5 g/dl.. Patients in this study had impaired QOL compared with population norms. Early treatment with epoetin alfa to correct anemia improved QOL in a statistically significant and clinically meaningful way, and improvements were greater in patients with baseline Hb levels >10.5 g/dl.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Platinum Compounds; Quality of Life; Recombinant Proteins; Reference Values; Sickness Impact Profile; Treatment Outcome

This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes.. Patients with Hb levels < or =12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (< or =9.7 g/dl, >9.7 g/dl to < or =10.5 g/dl, >10.5 g/dl to < or =11.3 g/dl, and >11.3 g/dl to < or =12.1 g/dl), and study results were reanalyzed.. Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to < or =12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to < or =12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group.. In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Blood Transfusion; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Platinum Compounds; Quality of Life; Recombinant Proteins; Sickness Impact Profile; Treatment Outcome

Anemia-related fatigue in cancer patients reduces health-related quality of life (HRQOL). These analyses evaluate the effect of hemoglobin level on fatigue and examine the relationship between improved fatigue and HRQOL. Data were collected during a multicenter, randomized trial involving 344 anemic patients with lymphoproliferative malignancies receiving chemotherapy and darbepoetin alfa or placebo. At baseline, interim study visits, and end of treatment, patients completed an HRQOL questionnaire. Improved hemoglobin levels were significantly associated (P < 0.001) with improved fatigue. Mean change in the Functional Assessment of Cancer Therapy (FACT) Fatigue score was 5.9 points greater when hemoglobin improved > 2 g/dl than when it declined. Patients experiencing a clinically meaningful improvement in fatigue reported significantly (P < 0.001) greater improvements in all other scales, except the FACT Social subscale. Managing anemia-related fatigue appears to have a positive impact on HRQOL, enhancing cancer patients' activity levels, mood, and perceived overall health.

Topics: Aged; Anemia; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Health Status; Hemoglobins; Humans; Leukemia, Lymphoid; Lymphoma; Male; Middle Aged; Quality of Life; Treatment Outcome

Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL).. Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for > or = 4 months of myelosuppressive chemotherapy were randomized to receive < or = 16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to < 9 g/dL (late). Those patients with a hemoglobin level > 12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total.. In all, 269 patients with a hemoglobin level < or = 12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21-7.46) in early patients and decreased 4.37 (95% CI, -7.99 to -0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98-1.46) in early patients but decreased 0.2 g/dL (95% CI, -0.32-0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients.. Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to < 9.0 g/dL.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematologic Neoplasms; Hemoglobins; Humans; Male; Middle Aged; Quality of Life; Recombinant Proteins; Work Capacity Evaluation

To study whether perioperative treatment with darbepoetin alfa (DA) improves physical performance following colorectal cancer surgery.. Patients admitted for planned colorectal cancer surgery were randomized to receive either weekly placebo or DA 300 or 150 microg depending on the hemoglobin (Hb) concentration. Patients were assessed 10 days before, as well as 7 and 30 days after surgery for work capacity, postural sway, muscle strength, fatigue and quality of life (QoL). The primary outcome measure were the changes in patients' physical performance from preoperative to postoperative day 7.. Of 221 included patients, 151 were evaluable. Baseline characteristics were similar in the 2 groups. Patients receiving DA had a significantly better working capacity on day 7 (p = 0.03) and day 30 (p = 0.03) compared with the placebo group. There were no statistically significant differences between the 2 groups on days 7 or 30 for fatigue, postural sway and QoL. DA treatment significantly (p < 0.01) reduced the decrease in Hb concentrations on day 7 and resulted in an earlier return (p < 0.01) to the preoperative Hb concentration compared to placebo treatment.. Perioperative DA treatment improved postoperative work capacity and Hb concentrations, but had no effect on postoperative fatigue, postural sway, QoL and muscle strength.

Topics: Activities of Daily Living; Aged; Colorectal Neoplasms; Darbepoetin alfa; Double-Blind Method; Erythropoietin; Exercise Test; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Muscle Strength; Perioperative Care; Quality of Life

Epoetin alfa administered at 40,000 U once weekly (qw) to anemic cancer patients receiving chemotherapy increases hemoglobin levels, improves quality of life (QOL), and reduces transfusions. The benefit of epoetin alfa in maintaining hemoglobin levels in cancer patients with hemoglobin less than 12 g/dL has not been evaluated.. Breast cancer patients (N = 354) receiving chemotherapy were randomly assigned in 1:1 ratio to epoetin alfa (40,000 U qw) or standard of care (SOC). QOL was assessed at baseline and week 12. Hemoglobin responses, transfusion requirements, and prognostic factors for responses were measured.. At week 12, Functional Assessment of Cancer Therapy-Anemia (FACT-An; mean, 2.16 +/- 12.84 for epoetin alfa v -4.43 +/- 13.42 for SOC) and FACT-An fatigue (mean, 1.85 +/- 10.52 for epoetin alfa v -3.55 +/- 11.14 for SOC) change scores were significantly higher in the epoetin alfa group (P < .0001). Hemoglobin responses defined as mean hemoglobin > or = 12 g/dL or a > or = 2 g/dL increase compared with baseline were significantly higher in the epoetin alfa group versus SOC: 52.0% v 5.1% and 65.7% v 6.3%, respectively (P < .0001 for both comparisons). Percentage transfused was significantly lower in the epoetin alfa group compared with SOC (8.6% v 22.9%). More than 90% of patients did not require a dose increase and 28.7% had a dose reduction.. Epoetin alfa administered at 40,000 U qw is effective in improving QOL, maintaining hemoglobin level, and reducing transfusion requirements in breast cancer patients. The high effectiveness observed could be attributed in part to early treatment with epoetin alfa.

Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Blood Transfusion; Breast Neoplasms; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Middle Aged; Quality of Life; Recombinant Proteins; Treatment Outcome

Impaired cognition, fatigue, and diminished quality of life (QOL) are commonly associated with breast cancer chemotherapy. This randomized, double-blind, placebo-controlled pilot trial assessed the feasibility of quantifying the effects of epoetin alfa on cognitive function and mood, and evaluated its effects on fatigue and QOL in patients with breast cancer treated with anthracycline-based adjuvant or neoadjuvant chemotherapy. Patients were randomized to receive epoetin alfa 40,000 U subcutaneously once weekly or placebo at the beginning of 4 cycles of chemotherapy administered over 12 weeks. Cognitive function was assessed by Executive Interview (EXIT25) and Clock Drawing Tasks; mood by Profile of Mood States; anemia-related symptoms, including fatigue, by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) subscale; and QOL by Linear Analog Scale Assessment. Ninety-four patients were evaluable for efficacy and safety. Mean change in EXIT25 scores from baseline to cycle 4 in the epoetin alfa group was 1.3 +/- 3.3; the mean change was 0.3 +/- 2.4 in the placebo group (a negative change indicates improved executive function). There was no difference between groups in mean change in EXIT25 score from baseline to 6-month follow-up assessment. Mean hemoglobin levels were higher in the epoetin alfa group compared with the placebo group after 4 cycles of chemotherapy. Epoetin alfa recipients had less of a decrease in FACT-An subscale scores from baseline to cycle 4 and improvement in FACT-An subscale scores at 6-month follow-up assessment compared with placebo. Epoetin alfa therapy was well tolerated. These data suggest that epoetin alfa may have attenuated the cognitive impairment and fatigue that occurred during adjuvant breast cancer chemotherapy.

Topics: Adult; Affect; Aged; Breast Neoplasms; Chemotherapy, Adjuvant; Cognition Disorders; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Injections, Subcutaneous; Middle Aged; Neoadjuvant Therapy; Placebos; Quality of Life; Recombinant Proteins; Treatment Outcome

This prospective, open-label, multicenter study was undertaken to determine the safety and efficacy of epoetin alfa in increasing hemoglobin levels and improving quality of life (QOL), specifically fatigue, in cancer patients receiving chemotherapy with or without radiotherapy (n=702). Epoetin alfa, 10,000 IU three times a week s.c. for 8-18 weeks, increased the mean hemoglobin level relative to baseline (1.0 +/- 1.5 g/dl by week 4 and > or =1.7 g/dl from week 10 through the end of the trial), with 63.4% of patients experiencing > or =2 g/dl increases in hemoglobin above baseline at some time during the study. Fatigue is an important component of QOL. Physicians, nurses, and patients independently assessed patient fatigue level on a linear-analogue scale. Although all three groups reported improvements in patient fatigue over the course of the study (p <.0001), the magnitude of fatigue ratings and their relationship to tumor response and to hemoglobin level varied by group. Overall, epoetin alfa was well tolerated and effective in improving hemoglobin levels and decreasing fatigue in patients undergoing chemotherapy.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Prospective Studies; Quality of Life; Recombinant Proteins; Treatment Outcome

Cancer-related anaemia is associated with fatigue that adversely affects patients' everyday functioning and wellbeing. We explore the impact of fatigue on patient productivity and caregiver burden.. The analyses are based on data from a randomised, open-label, active-controlled, dose-finding trial of darbepoetin alfa among solid-tumour cancer patients with anaemia, who are receiving chemotherapy. Fatigue is assessed with the Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score. Productivity and caregiver outcomes include time (hours) missed from usual activities, amount of assistance (hours) needed from others, overall ability to perform desired activities and ability to perform family responsibilities. These outcomes are assessed at baseline and the end of the 12-week treatment period. ANOVA and linear regression models are used to evaluate associations.. Patients (n=300) were aged 61 years on average, with a mean (SD) baseline haemoglobin of 9.9 (0.9) g/dL. FACT-Fatigue subscale score improvements were significantly (p=0.003) associated with haemoglobin improvements. Over a 2-week period, after controlling for age, sex and disease progression, one-point improvements in FACT-Fatigue subscale scores corresponded to a 1-hour (95% CI 0.5, 1.5) gain in productive time, 0.7-hour (95% CI 0.4, 1.0) reduction in caregiver time and 1.6% (95% CI 1.4, 1.7) improvement in overall activity.. Reducing fatigue is associated with gains in productive time, reductions in caregiver burden and enhanced ability to perform activities. These outcomes may have broader implications for patients' wellbeing and for the societal impact of cancer-related fatigue and anaemia.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Darbepoetin alfa; Dose-Response Relationship, Drug; Efficiency; Erythropoietin; Fatigue; Female; Humans; Male; Middle Aged; Neoplasms

We evaluated Darbepoetin alpha (Aranesp; Amgen), a novel erythropoietic protein, in patients who developed anemia while receiving chemotherapy. Seventy-five patients (median age 62 years, range 40-81 years) undergoing different cancer chemotherapy regimens were treated with darbepoetin alpha. Therapy was started if hemoglobin (Hb) levels fell below 10 g/dl or if symptomatic anemia developed. Treatment effect was evaluated after 4 weeks, 8 weeks and at the end of therapy (up to 12 weeks). If no increase in Hb was seen after 4 weeks, the dose of darbepoetin alpha was increased to 300 microg. Patients were questioned about fatigue and any change during treatment, with evaluation according to a four-point scale, where 0 = no fatigue and 3 = severe fatigue. We observed a treatment response in 54 of 75 patients (72%). Dose escalation was necessary in 30 of 75 patients (40%) and blood transfusions were required in 13 of 75 patients (17.3%). Response was observed in 32 of 43 patients (74.4%) who had a baseline Hb < 10 g/dl and in 22 of 32 (68.8%) patients who had a baseline Hb > or =10 g/dl. At baseline, 60 of 75 patients (93.3%) reported fatigue of grade 2 or 3, but at the end of the 12-week follow-up period, only 26 of 68 patients (38.3%) reported fatigue at these levels. We conclude that darbepoetin alpha is a highly effective and well-tolerated drug in the treatment of chemotherapy-associated anemia. Patients benefited both in terms of Hb levels and control of chemotherapy-related symptoms.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Middle Aged; Neoplasms; Prospective Studies; Quality of Life

Fatigue can be a major problem for cancer patients receiving chemotherapy, and anaemia is known to be an important contributory factor. Several studies have shown that treatment with epoetin alfa raises haemoglobin levels, reduces fatigue and improves health-related quality of life (HrQoL). However, it is often difficult for clinicians to relate reported HrQoL improvements from clinical trials to meaningful benefits for their patients. Results from a large-scale, placebo-controlled study were used to determine the minimally important difference in HrQoL, defined as the 'smallest difference in score...which patients perceive as beneficial and which would mandate...a change in the patient's management'. This analysis confirmed that, for the five QoL scales used, epoetin alfa conferred not only a statistically significant but also a clinically significant benefit in terms of QoL compared to placebo, since, in each case, the benefit associated with epoetin alfa use was considerably higher than the minimally important difference.

Topics: Adult; Anemia; Antineoplastic Agents; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Humans; Male; Neoplasms; Placebos; Quality of Life; Recombinant Proteins

Anemia, fatigue, and diminished quality of life (QOL) often are associated with chemotherapy. In a previous study of patients with early-stage breast cancer and a mean baseline hemoglobin (Hb) level of 12.1 g/dL, Hb decreased by 2.0 g/dL after 4 cycles of adjuvant chemotherapy. The current open-label, nonrandomized, multicenter, prospective, community-based study evaluated the effects of 12-24 weeks of epoetin alfa (40,000 U subcutaneously once weekly initiated at the start of standard adjuvant chemotherapy) in patients with stage I-III breast cancer and baseline Hb levels > or =10 g/dL to < or =14 g/dL on Hb level, transfusions, and QOL.. Of 1792 patients enrolled, 1785 were evaluable for safety and 1632 for efficacy. Mean age was 53 years +/- 10.7 and mean baseline Hb level was 12.3 g/dL +/- 1.0. From baseline levels, epoetin alfa significantly increased Hb (1.3 g/dL +/- 1.5; P < 0.05) and improved QOL according to the Linear Analog Scale Assessment (LASA) of energy (5.1 mm +/- 27.7), LASA activity (5.1 mm +/- 28.2), LASA overall QOL (4.3 mm +/- 26.7), and Functional Assessment of Cancer Therapy-Anemia (1.7 points +/- 14.0; P < 0.05 in each case). Patients with baseline mild anemia (Hb level >10 g/dL to < or =12 g/dL) also had significant improvements from baseline levels in all 3 LASA parameters (P < 0.05). Epoetin alfa was well tolerated; clinically relevant thrombovascular events were reported in 4.3% of patients.. In this study, epoetin alfa significantly improved Hb and QOL in mildly anemic patients with early-stage breast cancer receiving adjuvant chemotherapy. However, based on recent studies showing an increased risk of thrombovascular events in patients with cancer treated with erythropoietic agents beyond correction of anemia, treatment with epoetin alfa is not indicated or recommended in patients with cancer and Hb levels > 12 g/dL.. Controlled studies are warranted to confirm the safety and efficacy of epoetin alfa therapy in patients with mild anemia receiving chemotherapy.

Topics: Adult; Anemia; Breast Neoplasms; Chemotherapy, Adjuvant; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Middle Aged; Prospective Studies; Quality of Life; Recombinant Proteins; Severity of Illness Index; Treatment Outcome

Currently, there is some debate concerning the haemoglobin level at which treatment of anaemia with erythropoiesis-stimulating agents should be initiated in cancer patients on chemotherapy. We report several analyses of data from a phase III trial of darbepoetin alfa versus placebo, comparing outcomes for patients with mild and moderate-to-severe anaemia.. Data were obtained from a phase III trial of darbepoetin alfa versus placebo in anaemic patients with lung cancer receiving chemotherapy ( n=314). Outcomes were compared for patients with baseline haemoglobin > or =10-11 g/dl and <10 g/dl.. Darbepoetin alfa significantly reduced transfusions compared with placebo, irrespective of haemoglobin level at treatment initiation. For patients with baseline haemoglobin <10 g/dl, 31% and 59% of those receiving darbepoetin alfa and placebo, respectively, required a transfusion from week 5 to the end of the treatment phase ( P<0.038). For patients with baseline haemoglobin > or =10 g/dl, the proportions were 15% and 41%, respectively ( P<0.001). Darbepoetin alfa also improved fatigue compared with placebo in both haemoglobin categories.. These findings show that initiating treatment at haemoglobin levels both <10 g/dl and > or =10-11 g/dl results in substantial clinical benefits, supporting the use of erythropoietic therapy also in patients with mild anaemia.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Chi-Square Distribution; Darbepoetin alfa; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Lung Neoplasms; Male; Middle Aged; Placebos; Retrospective Studies; Treatment Outcome

In this prospective study we evaluate the effects of high-dose recombinant human erythropoietin (rHuEPO) on quality of life (QOL) and brain function in patients with low-risk myelodysplastic syndromes (MDS) (<10% marrow blasts). Preliminary data are reported.. Eleven consecutive patients were given rHuEPO (40,000 IU two times a week) for 12 wk. Responsive patients continued with 40,000 IU/wk for further 12 wk. Changes in QOL were assessed by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) self-report. Neurophysiological evaluation at the start of the therapy (t0) included duplex scanning of neck vessels, transcranial Doppler sonography (TCD), a complex neuropsychological evaluation, and quantitative electroencephalography (qEEG). Eight patients completed the neurophysiological evaluation after 24 wk (t1).. Six patients (55%) achieved an erythroid response after 12 wk, which was maintained after 24 wk of treatment. FACT-An score showed a relevant improvement between t0 and t1 in these patients. At baseline, TCD showed a mean cerebral blood flow (CBF) velocity in the upper normal range. Abnormalities in brain function were observed in five patients. In the eight patients who were re-evaluated at t1, improvement was observed in three responding patients, two of them with abnormal values at t0. A strict correlation between QOL and neurophysiological improvements was not observed.. A high-dose induction phase with rHuEPO followed by maintenance therapy may be an effective therapeutic schedule for low-risk MDS patients. The erythroid response was associated with positive changes in the QOL. Neurophysiological improvements occurred only in a part (50%) of responding patients, mainly those who showed altered results at baseline.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Brain; Electroencephalography; Erythropoietin; Fatigue; Humans; Middle Aged; Myelodysplastic Syndromes; Neuropsychological Tests; Patient Selection; Quality of Life; Recombinant Proteins; Surveys and Questionnaires

Recombinant human erythropoietin (r-HuEPO) corrects cancer-related anemia and, thereby, improves quality of life. The purpose of the present study was to measure the impact of erythropoietin on hemoglobin and mood state in patients with metastatic breast cancer and mild anemia (Hgb < 12.0 g/dL). Women were randomized to receive usual care (G1) or usual care plus r-HuEPO (G2). Usual care included transfusions as necessary and fatigue education. R-HuEPO was begun at 40,000U subcutaneously per week. At 4 weeks, the dose was increased to 60,000U if Hgb had not increased > or = 1.0 g/dL. The drug was discontinued at 8 weeks if hemoglobin improvement was < 1.0 g/dL. The study was terminated early (n = 27, G1 = 13, G2 = 14) when 4/14 (28.5%) subjects in G2 developed thrombotic events (deep vein thrombosis [DVT] in 1; DVT plus pulmonary embolism [PE] in 1; DVT plus PE 1 month after drug discontinuation in 1; and brachial vein thrombosis with infected Mediport in 1). In all four patients, Hgb levels were normal at the time of the event. No patient in G1 developed a thrombotic event. There were no significant differences in demographic characteristics or current chemotherapy regimen in G1 vs. G2. The decision to terminate the trial was made after considerable deliberation. The increased incidence of thrombotic events in the r-HuEPO (G2) arm of this study exceeds that in prior studies in this population and prior r-HuEPO trials. This may relate to the administration of r-HuEPO in this high-risk population, but the small sample size and possible predisposing risk factors preclude definitive conclusions.

Topics: Anemia; Breast Neoplasms; Erythropoietin; Fatigue; Female; Humans; Middle Aged; Palliative Care; Quality of Life; Recombinant Proteins; Thrombosis; Treatment Outcome; Withholding Treatment

Anemia, highly common among cancer patients, is often an underlying cause of cancer-related fatigue and other quality-of-life (QOL) deficits. Although randomized clinical trials have shown that treatment with epoetin alfa increases hemoglobin levels, reduces fatigue, lessens transfusion requirements, and improves overall QOL, cancer-related anemia and fatigue remain undertreated. This is, in part, because scales and measures of QOL are still relatively unfamiliar to most clinicians and because population-based reference ranges are lacking, thus making clinical trial results difficult to interpret.. To aid in the interpretation of QOL results from clinical trials, we administered the Functional Assessment of Cancer Therapy-Anemia (FACT-An) QOL instrument to a nationally representative sample of 1,400 people using an Internet survey panel in the United States. We then compared the FACT-An data from the Internet survey with the QOL data of a 375-patient randomized, double-blind clinical trial evaluating epoetin alfa versus placebo in anemic cancer patients.. FACT-An, as administered to the survey population, displayed good psychometric properties and was able to discriminate between respondents with histories of specified illnesses, including anemia and cancer, and those without. Comparison of the population norm and clinical trial data showed that treatment with epoetin alfa resulted in clinically meaningful as well as statistically significant improvements in QOL (P <.01).. Reliable population norm data are now available to aid in the interpretation of clinical trial results where the FACT-An questionnaire is administered. In the clinical trial, treatment with epoetin alfa overcame much of the QOL deficit seen in anemic cancer patients compared with the norm population sample.

Topics: Adolescent; Anemia; Blood Transfusion; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Health Status Indicators; Hematinics; Hemoglobins; Humans; Neoplasms; Quality of Life; Recombinant Proteins; Surveys and Questionnaires; Treatment Outcome

Anemia in patients receiving chemotherapy can be ameliorated with recombinant human erythropoietin (rHuEPO), which is administered one to three times per week. Darbepoetin alpha, a new erythropoietic agent, has longer serum residence time, allowing it to be administered less frequently.. Patients (n = 127) were randomized to receive study drug for 12 weeks: either rHuEPO 40,000 U with escalations to 60,000 U for nonresponders or darbepoetin alpha at doses of 4.5 microg/kg per week until hemoglobin concentration >or= 12 g/dL, then 1.5 microg/kg per week (Group 1); 4.5 microg/kg per week for 4 weeks, then 2.25 microg/kg per week for 8 weeks (Group 2); or 4.5 microg/kg per week for 4 weeks, then 3.0 microg/kg every 2 weeks (Group 3). Efficacy was measured using the mean change in hemoglobin level, the proportion of patients achieving a hemoglobin response, the time to response, and the mean change in Functional Assessment of Cancer Therapy-Fatigue Scale scores. Safety was assessed by reports of adverse events.. Overall, after 4 weeks of treatment, the mean change (95% confidence interval [95%CI]) in hemoglobin concentration was 0.53 g/dL (95%CI, 0.05-1.02 g/dL), 0.70 g/dL (95%CI, 0.11-1.29 g/dL), and 0.90 g/dL (95%CI, 0.47-1.33 g/dL) in darbepoetin alpha Groups 1, 2, and 3, respectively, and 0.39 g/dL (95%CI, - 0.22-1.00 g/dL) in the rHuEPO group. By the end of the study, the mean change (95%CI) in hemoglobin concentration was 1.35 g/dL (95%CI, 0.67-2.02 g/dL), 1.35 g/dL (95%CI, 0.57-2.12 g/dL), and 1.28 g/dL (95%CI, 0.84-1.73 g/dL) in darbepoetin alpha Groups 1, 2, and 3, respectively, and 1.03 g/dL (95%CI, 0.53-1.53 g/dL) in the rHuEPO group. The early erythropoietic response in patients who were treated with darbepoetin alpha was associated with an early and maintained reduction in patient-reported fatigue. The adverse event profile was comparable with all doses of darbepoetin alpha and rHuEPO.. Darbepoetin alpha, given as a front-loaded dose for 4 weeks and followed by lower and/or less frequent doses, appears to be efficacious and may decrease the time to response relative to treatment with rHuEPO.

Topics: Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Darbepoetin alfa; Deoxycytidine; Docetaxel; Erythropoietin; Fatigue; Female; Gemcitabine; Humans; Injections, Subcutaneous; Male; Middle Aged; Neoplasms; Paclitaxel; Pilot Projects; Taxoids; Treatment Outcome

This phase 3, randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Patients (n = 344) with lymphoma or myeloma received darbepoetin alfa 2.25 microg/kg or placebo s.c., once weekly for 12 weeks. The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group (60%) than in the placebo group (18%) (P < 0.001), regardless of baseline endogenous erythropoietin level. However, increased responsiveness was observed in patients with lower baseline erythropoietin levels. Darbepoetin alfa also resulted in higher mean changes in haemoglobin than placebo from baseline to the last value during the treatment phase (1.80 g/dl vs 0.19 g/dl) and after 12 weeks of treatment (2.66 g/dl vs 0.69 g/dl). A significantly lower percentage of patients in the darbepoetin alfa group received red blood cell transfusions than in the placebo group (P < 0.001). The efficacy of darbepoetin alfa was consistent for patients with lymphoma or myeloma. Improvements in quality of life were also observed with darbepoetin alfa. The overall safety profile of darbepoetin alfa was consistent with that expected for this patient population. Darbepoetin alfa significantly increased haemoglobin and reduced red blood cell transfusions in patients with lymphoproliferative malignancies receiving chemotherapy.

Topics: Aged; Analysis of Variance; Anemia; Blood Transfusion; Darbepoetin alfa; Diarrhea; Double-Blind Method; Erythropoietin; Fatigue; Female; Fever; Follow-Up Studies; Humans; Linear Models; Lymphoma; Lymphoproliferative Disorders; Male; Middle Aged; Multiple Myeloma; Nausea; Quality of Life

Patients receiving chemotherapy often develop anemia. Darbepoetin alfa (Aranesp(TM)) is an erythropoiesis-stimulating glycoprotein that has been shown, in dose-finding studies, to be safe and clinically active when administered to patients with cancer every 1, 2, or 3 weeks. This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy.. In this multicenter, double-blind, placebo-controlled study, 320 anemic patients (hemoglobin or=25% improvement; mean difference = 13%; 95% CI = 2% to 23%, P =.019) than patients receiving placebo. Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug. Adverse events were similar between the groups.. Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy. Darbepoetin alfa decreased blood transfusion requirements, increased hemoglobin concentration, and decreased fatigue. Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Darbepoetin alfa; Disease Progression; Double-Blind Method; Erythrocyte Transfusion; Erythropoiesis; Erythropoietin; Fatigue; Female; Humans; Length of Stay; Lung Neoplasms; Male; Middle Aged; Patient Admission; Platinum Compounds; Surveys and Questionnaires; Survival Analysis; Treatment Outcome

Anaemia is a common haematologic disorder in patients with cancer and has a multifactorial aetiology, including the effects of the malignancy itself and residual effects from previous therapy. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa), a protein with additional sialic acid compared with erythropoietin (EPO), stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO) but it is biochemically distinct. NESP, with its approximately 3-fold greater serum half-life, can maintain haemoglobin levels as effectively as rHuEPO in anaemic patients with chronic renal failure and do so with less frequent dosing. We investigated the ability of NESP to safely increase haemoglobin levels of anaemic patients with non-myeloid malignancies not receiving chemotherapy. NESP was administered under the supervision of a physician at doses of 0.5, 1.0, 2.25 or 4.5 mcg kg(-1)wk(-1)for a maximum of 12 weeks. This report includes 89 patients completing the study by November 2000. NESP was well tolerated, with no reported dose-limiting toxicities or treatment-related severe adverse events. Increasing doses of NESP corresponded with increased efficacy. The percentage (95% confidence interval) of patients responding ranged from 61% (42%, 77%) in the 1.0 mcg kg(-1)wk(-1)group to 83% (65%, 94%) in the 4.5 mcg kg(-1)wk(-1)group.

Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Combined Modality Therapy; Darbepoetin alfa; Dose-Response Relationship, Drug; Drug Administration Schedule; Erythrocyte Transfusion; Erythropoiesis; Erythropoietin; Fatigue; Female; Half-Life; Hemoglobins; Humans; Injections, Subcutaneous; Life Tables; Male; Middle Aged; N-Acetylneuraminic Acid; Neoplasms; Quality of Life; Recombinant Proteins; Safety; Treatment Outcome

This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival.. Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL, or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study.. Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P =.0057) and increased hemoglobin (P <.001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P <.01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P =.13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P =.052) favoring epoetin alfa. Adverse events were comparable between groups.. Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.

Topics: Activities of Daily Living; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Double-Blind Method; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Placebos; Quality of Life; Recombinant Proteins; Survival Analysis; Treatment Outcome

To prospectively evaluate the effectiveness, safety, and clinical benefits of once-weekly epoetin alfa therapy as an adjunct to chemotherapy in anemic cancer patients.. A total of 3,012 patients with nonmyeloid malignancies who received chemotherapy were enrolled onto this multicenter, open-label, nonrandomized study conducted in 600 United States community-based practices. Patients received epoetin alfa 40,000 U once weekly, which could be increased to 60,000 U once weekly after 4 weeks dependent on hemoglobin response. Treatment was continued for a maximum of 16 weeks.. Among the 2,964 patients assessable for efficacy, epoetin alfa therapy resulted in significant increases in hemoglobin levels, decreases in transfusion requirements, and improvements in functional status and fatigue as assessed by the linear analog scale assessment (energy level, ability to perform daily activities, and overall quality of life) and the anemia subscale of the Functional Assessment of Cancer Therapy-Anemia questionnaire. Improvements in quality-of-life parameters correlated significantly (P <.001) with increased hemoglobin levels. The direct relationship between hemoglobin and quality-of-life improvement was sustained during the 16-week study period, which is similar to findings of large community-based trials of three-times-weekly dosing. Once-weekly epoetin alfa was well tolerated, with most adverse events attributed to the underlying disease or concomitant chemotherapy.. The results from this large, prospective, community-based trial suggest that once-weekly epoetin alfa therapy increases hemoglobin levels, decreases transfusion requirements, and improves quality of life in patients with cancer and anemia who undergo concomitant chemotherapy. Based on the results of this study, the clinical benefits and the adverse event profile of once-weekly epoetin alfa therapy in community-based practice are similar to those observed in the historical experience with the three-times-weekly dosage schedule.

Topics: Activities of Daily Living; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Drug Administration Schedule; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Injections, Subcutaneous; Male; Middle Aged; Neoplasms; Prospective Studies; Quality of Life; Recombinant Proteins; Treatment Outcome

The cost of managing anemia with prophylactic epoetin alfa therapy versus blood transfusions in breast cancer patients receiving combination chemotherapy was studied. A retrospective study of anemia in breast cancer patients treated with four cycles of cyclophosphamide and doxorubicin with fluorouracil (CAF) or without fluorouracil (CA) was conducted. For each cycle of chemotherapy, patients were assessed for fatigue, subsequent blood transfusions administered, and potential response to and adverse effects of blood transfusions. Transfusions were given at the prescriber's discretion rather than in accordance with standard guidelines. The lowest hemoglobin concentration and hematocrit of each patient per cycle were reported. Data on these patients, along with data from published studies of prophylactic use of epoetin alfa, were used in a decision analysis of the costs associated with using epoetin alfa versus red blood cell transfusions to manage anemia. The charts of 50 patients were reviewed. In the study group, the percentage of patients with anemia and the frequency of fatigue rose with each chemotherapy cycle. In general, blood transfusions were not used. The cost of using epoetin alfa prophylactically for all four cycles was estimated at $6483 per patient for the literature-based group versus $169 for the study group. The cost of managing anemia in breast cancer patients was substantially lower when blood transfusions were used than when epoetin alfa was given prophylactically throughout four cycles of therapy with CAF or CA; the absence of standard guidelines for transfusion might have exaggerated the difference in costs.

Topics: Anemia; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Decision Trees; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Hematinics; Humans; MEDLINE; Recombinant Proteins; Retrospective Studies

A disease-specific questionnaire was developed for patients receiving chronic hemodialysis by interviewing patients to determine which aspects of their quality of life were adversely affected by their disease. The final questionnaire contained 26 questions in five dimensions (physical symptoms, fatigue, depression, relationships with others, frustration). The questionnaire demonstrated construct validity when compared with the Sickness Impact Profile, time trade-off technique and an exercise stress test. It was reproducible in stable, placebo-treated patients (correlation coefficient 0.85-0.98 for the 5 dimensions). It was more responsive than other measures in detecting an improvement with erythropoietin therapy in a randomized, placebo-controlled trial. This questionnaire should be useful for the assessment of the effect of various interventions upon the quality of life of hemodialysis patients.

Topics: Anemia; Depression; Double-Blind Method; Erythropoietin; Fatigue; Humans; Kidney Diseases; Quality of Life; Recombinant Proteins; Renal Dialysis; Surveys and Questionnaires

Topics: Activities of Daily Living; Adult; Double-Blind Method; Erythropoietin; Fatigue; Female; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Renal Dialysis; Work Capacity Evaluation

Topics: Aged; Carcinoma, Renal Cell; Diagnosis, Differential; Dizziness; Erythropoietin; Fatigue; Humans; Kidney Neoplasms; Lung Neoplasms; Male; Nephrectomy; Polycythemia; Tomography, X-Ray Computed; Treatment Outcome

Topics: Aged; Anemia, Macrocytic; Bone Marrow; Erythropoietin; Fatigue; Humans; Lenalidomide; Myelodysplastic Syndromes; Stem Cell Transplantation; Thalidomide

Fatigue is a common symptom in patients receiving hemodialysis (HD) and is generally associated with anemia. However, it can be difficult to resolve, even when anemia has been treated using erythropoiesis-stimulating agents and iron replacement therapy. In the present study, we examined the associations of anemia, the erythropoietin resistance index (ERI) and iron deficiency with fatigue during HD.. In this cross-sectional study, fatigue score was calculated on the basis of questionnaire responses in HD patients. Participants were divided into 3 groups according to their hemoglobin (Hb) levels (low, normal and high). Iron deficiency was assessed as a transferrin saturation (TSAT) of <20%.. We included 571 HD patients (men/women 368/203; mean age 62.2 ± 10.8 years). Among the 3 groups, fatigue scores increased significantly with decreasing Hb levels. HD patients with low Hb levels (<90 g/l) had significantly higher fatigue scores than those with higher Hb levels (≥120 g/l). In the multiple regression analysis, we showed that a high ERI (β = 0.208) and a low TSAT (β = -0.155), but not the Hb level, were significantly associated with increased fatigue score. Moreover, this was independent of age, gender and modifiable confounders linked to anemia. Even after restricting patients to those without iron deficiency (TSAT ≥20%), the ERI (β = 0.258) retained a significant and independent association with the fatigue score.. Iron deficiency and a high ERI despite iron sufficiency may cause fatigue in HD patients.

Topics: Aged; Cross-Sectional Studies; Erythropoietin; Fatigue; Female; Humans; Male; Middle Aged; Multivariate Analysis; Renal Dialysis

Myelofibrosis (MF) is characterized by shortened survival and a greatly compromised quality of life. Weight loss and cachexia seem to be the most important factors influencing survival in patients with MF. The aim of this study was to assess the efficacy of an integrated supportive therapy in improving cachexia and MF-related symptoms.. We reported on a case of a patient with MF who presented with weight loss and cachexia associated with severe anemia, fatigue, fever, and bone pain. The circulating levels of inflammatory, oxidative stress parameters, hepcidin, and erythropoietin were evaluated and were above normal ranges. The patient was treated with a multitargeted approach specifically developed for cachexia including oral l-carnitine, celecoxib, curcumin, lactoferrin, and subcutaneous recombinant human erythropoietin (EPO)-α.. Surprisingly, after 1 y, cachexia features improved, all MF symptoms were in remission, and inflammatory and oxidative stress parameters, hepcidin, and EPO were reduced.. Because our protocol was targeted at inflammation and the metabolic state, its effectiveness may emphasize the role of inflammation in the pathogenesis of MF symptoms and demonstrates a need for the study of new integrated therapeutic strategies.

Topics: Anemia; C-Reactive Protein; Cachexia; Carnitine; Celecoxib; Curcumin; Erythropoietin; Fatigue; Ferritins; Fever; Hepcidins; Humans; Interleukin-6; Iron; Lactoferrin; Male; Middle Aged; Oxidative Stress; Patient Compliance; Primary Myelofibrosis; Quality of Life; Reactive Oxygen Species; Recombinant Proteins; Treatment Outcome; Tumor Necrosis Factor-alpha; Weight Loss

In this study we investigated the relationship between health-related quality of life, fatigue, and activity levels of people with anemia secondary to chronic kidney disease over a 12 month period following the introduction of an erythropoietin-stimulating agent. Using a longitudinal repeated-measure design, 28 people with chronic kidney disease completed the Short Form-36 Health Survey, Human Activity Profile and Fatigue Severity Scale at the commencement of an erythropoietin-stimulating agent, and then at 3, 6, and 12 months. Over a 12 month period, a significant change was found for health-related quality of life in relation to role-physical, vitality, mental health/emotional well-being, and overall mental health. However, activity levels did not significantly improve during that time. Renal nurses in dialysis units and chronic kidney disease outpatient clinics have repeated and frequent contact with people with chronic kidney disease over long periods of time, and are in an ideal position to routinely assess fatigue and activity levels and to institute timely interventions to optimize health-related quality of life and independent activity.

Topics: Activities of Daily Living; Adult; Age Factors; Aged; Aged, 80 and over; Analysis of Variance; Anemia; Cohort Studies; Erythropoietin; Fatigue; Female; Humans; Kidney Failure, Chronic; Longitudinal Studies; Male; Middle Aged; Monitoring, Physiologic; Motor Activity; New South Wales; Quality of Life; Queensland; Renal Dialysis; Risk Assessment; Severity of Illness Index; Sex Factors

The PERFORM Questionnaire is a 12-item scale developed for assessing fatigue in cancer patients in the clinical practice. It has advantages over other tools in that it is short and includes beliefs and attitudes of patients about fatigue. It was psychometrically validated in cancer patients with and without anemia.. We evaluated the usefulness of the PERFORM scale to measure fatigue in a large study focusing exclusively on anemic patients.. This was an observational, multicenter, prospective, 3-month study in cancer patients with hemoglobin (Hb)≤11 g/dl. Fatigue was assessed using the PERFORM questionnaire. The overall score ranges from 12 (no fatigue) to 60 (maximum fatigue).. We included 667 patients: 54.1 % women, mean age 60 (standard deviation, 12) years. A highly significant, but mild correlation was observed between low baseline Hb and high patient perception of fatigue (r with PERFORM score=-0.215, p < 0.0001). Of the patients, 65.8 % improved Hb level during follow-up (increase of ≥1 g/dL and/or achieving >11 g/dL), which translated into a significant improvement in the PERFORM score [mean (95 % confidence interval (CI)] change, -1.2 (-0.04 to -2.4), whereas more fatigue was observed in patients without improvement in Hb [change (95 % CI) in PERFORM, +3.3 (1.5 to 5)]. In a multivariate linear regression analysis, the independent factors associated to fatigue at 3 months were a low Hb level, a low Karnofsky index, active chemotherapy, cancer treatment with palliative intention, and transfusion need in the last 3 months.. Minimal increases or decreases in Hb of ≥1 g/dL were associated with meaningful changes in patient-perceived fatigue as measured with the PERFORM questionnaire. In addition to anemia severity, other factors such as active chemotherapy and advanced disease contribute to perception of fatigue by cancer patients.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Karnofsky Performance Status; Male; Middle Aged; Neoplasms; Prospective Studies; Psychometrics; Surveys and Questionnaires; Young Adult

This analysis examined the effects of darbepoetin alfa on hemoglobin and fatigue outcomes in patients with cancer using latent growth curve modeling (LGM).. Data from 4 clinical trials of darbepoetin alfa in lung cancer (2 studies; n = 547; n = 288), lymphoproliferative malignancies (n = 339), and non-myeloid malignancies (n = 320) were analyzed separately. Fatigue was assessed using the FACT-Fatigue (FACT-F) scale. Effects of darbepoetin alfa on changes in hemoglobin and FACT-F scores were evaluated using LGM, controlling for age, gender, Eastern Cooperative Oncology Group performance status, health status, and total transfusions.. Patients receiving darbepoetin alfa had higher rates of change in hemoglobin (standardized regression coefficient [[Formula: see text]] = 0.30 to 0.53, all P < 0.05) than placebo. Patients with greater rates of change in hemoglobin reported improvements in fatigue outcomes ([Formula: see text] = 0.28 to 0.59, all P < 0.05). The total standardized effect of darbepoetin alfa on fatigue outcomes corresponded to a mean change of 0.9 to 3.5 points in FACT-F scores, with one trial demonstrating changes exceeding the minimal important difference of 3 points.. Darbepoetin alfa improved hemoglobin which was associated with improved fatigue across the 4 trials. Clinically, meaningful improvement in fatigue was seen in 2 trials. More complex statistical analysis models of treatment may assist in understanding the effects of erythropoiesis-stimulating agents on patient-reported outcomes.

Topics: Aged; Anemia; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Randomized Controlled Trials as Topic; Treatment Outcome

Tumor anemia is very common in patients with cancer. The causes are very diverse and the parameter value depends on several factors. If this however develops to be symptomatic it may adversely impact health related quality of life. Erythropoietin or blood transfusion provides options for treatment. However, these are not always uneventful. There could also be a lack of response to Erythropoietin. This case report describes the complexity of tumor anemia. It also includes a more detailed discussion on the Fatigue Syndrome, which is one of the most common symptoms of patients with cancer. In the context of palliative care there is often the question of alternatives for improving the quality of patients life. Some kinds of treatment may also cause the opposite effect. A multidimensional assessment should help to approach this difficult issue and to find ways for a meaningful treatment of the symptoms of anemia.

Topics: Adenocarcinoma; Aged; Anemia; Bone Neoplasms; Breast Neoplasms; Combined Modality Therapy; Darbepoetin alfa; Disease Progression; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Hematinics; Humans; Medical Futility; Neoplasm Staging; Palliative Care; Quality of Life; Treatment Failure; Treatment Outcome

Anemia in oncology is no longer seen only as a side effect of chemotherapies. This comorbidity may be multifactorial, clinically and, for example, may be rather chronic when the patient has chronic renal failure associated, resulting in renal anemia. Similarly, the presence of iron deficiency, which can be solely responsible or contributing factor of anemia, is also a factor to be taken into account in both the diagnosis and exploration of anemia and in its treatment, requiring the use of injectable iron complexes for treatment, if necessary in combination with an erythropoiesis agent stimulating.

Topics: Anemia; Antineoplastic Agents; Erythropoiesis; Erythropoietin; Fatigue; Hematinics; Humans; Iron; Iron Deficiencies; Iron, Dietary; Kidney Failure, Chronic; Neoplasms; Practice Guidelines as Topic

The anomalous EVI1 rearrangements/t(3;3)(q21;q26) is more frequently found in myelocytic malignancies. 5q- syndrome is a newly defined subtype of myelodysplastic syndrome (MDS) first proposed by the World Health Organization in 2001. Cases of acute lymphocytic leukemia (ALL) with 5q- anomaly or t(3;3)/EVI1 rearrangement have rarely been reported. We report a rare 5q- syndrome case which ultimately transformed to acute lymphocytic leukemia accompanied by a secondary cytogenetic anomaly of t(3;3)(q21;q26) and EVI1 rearrangement around 3 years after the diagnosis of 5q- syndrome. This rare case suggests that the 5q- clone of MDS may originate from a multipotent cell with a capacity to differentiate toward both myeloid and lymphoid lineages. It also indicates that although the t(3;3)/EVI1 rearrangement is mostly related to myelocytic neoplasms, the t(3;3)/EVI1-rearrangement may also play an important role in the development of ALL. The results of the necessary tests must be analyzed sufficiently prior to making a final diagnosis.

Topics: Adult; Anemia, Macrocytic; Blood Transfusion; Bone Marrow; Cell Differentiation; Cell Lineage; Chromosome Deletion; Chromosomes, Human, Pair 3; Chromosomes, Human, Pair 5; Disease Progression; DNA-Binding Proteins; Erythropoietin; Fatal Outcome; Fatigue; Humans; Immunophenotyping; Karyotype; Male; MDS1 and EVI1 Complex Locus Protein; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Proto-Oncogenes; Testosterone; Thalidomide; Transcription Factors

This study investigated adherence to treatment guidelines on cancer-related anaemia and fatigue (CRA/CRF) and factors influencing the choice of intervention.. In this prospective, observational study, 136 cancer patients being treated with chemotherapy in a large community hospital completed a questionnaire at consecutive outpatient visits assessing fatigue (the Functional Assessment of Chronic Illness Therapy-Fatigue) and fatigue-related counselling and advice received. Data on administration of chemotherapy and use of epoetin or blood transfusions were abstracted from the medical records.. Fifty-three percent of patients with severe anaemia (Hb < 10 g/dl) and 6% of patients with less severe anaemia (Hb levels 10-12 g/dl) received treatment (epoetin and/or blood transfusions). Half of the patients with less severe anaemia reported clinically relevant levels of fatigue. More than 50% of all patients received fatigue-related counselling, primarily at the start of chemotherapy. Most counselling was directed at energy conservation. Fatigue was not associated significantly with the use of epoetin or blood transfusion. Patients receiving palliative treatment (17%), male patients (16%) and patients with a low Hb level (<6.2 g/dl, 38%) were treated significantly more often with epoetin.. In daily clinical practice, guidelines concerning the use of epoetin or blood transfusion in severe CRA are adhered to in about half of the cases. In patients with less severe anaemia, the level of fatigue did not play a significant role in the use of epoetin. According to current guidelines, counselling on CRF should be directed primarily at activity enhancement. However, only a minority of patients receive such counselling.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Blood Transfusion; Erythropoietin; Fatigue; Female; Guideline Adherence; Hospitals, Community; Humans; Male; Middle Aged; Neoplasms; Palliative Care; Patient Education as Topic; Practice Guidelines as Topic; Prospective Studies; Severity of Illness Index; Sex Factors

Cancer patients with chemotherapy-induced anaemia (CIA) often experience cancer-related fatigue (CRF). Darbepoetin alfa (DA) once every 3 weeks (q3w) is an effective and well tolerated erythropoiesis-stimulating agent. This study evaluated DA effectiveness and psychometric properties of the Functional Assessment of Cancer Therapy Fatigue-Subscale (FACT-F) and the Fatigue Symptom Inventory (FSI) in CIA patients.. This was a single-centre, prospective study in 100 patients with solid tumour and moderate to severe CRF (visual analogue scale [VAS-F] ≥ 30 mm) who received DA 500 μg q3w during chemotherapy (CT). Clinical data, VAS-F, FACT-F and FSI scores were collected at the beginning and at the end of CT (EOCT).. Mean age was 62.7 years (SD: 12.1), 53.0% were women, 92.0% had ECOG 0-1 and 64% had stage IV tumours. Mean haemoglobin (Hb) significantly increased from baseline 10.2 g/dl to 11.3 g/dl at EOCT. Sixty-five percent of patients showed haematopoietic response at any study point (Hb ≥ 12 g/dl or an increase of ≥ 2 g/dl from baseline), 77% achieved Hb ≥ 11 g/dl and 7% required blood transfusions from week 5 to EOCT. CRF improvement was demonstrated by significant changes in VAS-F, FACT-F and FSI scores (decreases of 21.54, 3.56 and 12.97 points, respectively). FACT-F and FSI questionnaires showed high internal consistency (Cronbach's alpha of 0.98 and 0.98 for FACT-F and FSI, respectively, at the end of study) and satisfactory intra-class coefficients (FACT-F, r=0.73; FSI, r=0.83). There were significant correlations between scores and Hb changes (FACT-F, r=-0.44; FSI, r=-0.54).. DA 500 μg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF.

Topics: Aged; Anemia; Antineoplastic Agents; Cohort Studies; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Longitudinal Studies; Male; Medical Oncology; Middle Aged; Prospective Studies; Quality of Life; Treatment Outcome

Hugh Montgomery's discovery of the first of more than 239 fitness genes together with rapid advances in human gene therapy have created a prospect of using genes, genetic elements, and cells that have the capacity to enhance athletic performance (to paraphrase the World Anti-Doping Agency's definition of gene doping). This brief overview covers the main areas of interface between genetics and sport, attempts to provide a context against which gene doping may be viewed, and predicts a futuristic legitimate use of genomic (and possibly epigenetic) information in sport.

Topics: Angiotensin-Converting Enzyme 2; Animals; Apolipoproteins E; Doping in Sports; Epigenesis, Genetic; Erythropoietin; Fatigue; Fatigue Syndrome, Chronic; Female; Gene Transfer Techniques; Genetic Predisposition to Disease; Genetic Therapy; Genome, Human; Humans; Insulin-Like Growth Factor I; Male; Myostatin; Peptidyl-Dipeptidase A; Receptors, Erythropoietin; Sex Determination Analysis; Sports

The health-related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo-controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months, who had a hemoglobin <9.0 g/dL, and did not have coronary artery disease or diabetes mellitus, were randomized to either receive placebo (n=40), or receive intravenous Epoetin alfa to achieve a target hemoglobin of 9.5-11.0 g/dL (n=40) or a target of 11.5-13.0 g/dL (n=38). Patients were followed for 6 months. The two Epoetin alfa-treatment groups were combined for all analyses performed. This post hoc analysis was conducted using an intent-to-treat repeated measures mixed model analysis of variance using Bonferroni's multiplicity correction. The Epoetin alfa-treated group showed a statistically significant improvement in the Kidney Disease Questionnaire symptom of fatigue in comparison with placebo. Additionally, the change in hemoglobin at 2 months was correlated with change in fatigue, energy, shortness of breath, and weakness, but had minimal effect on depression. These analyses confirm previously reported results, which indicate that treating hemodialysis patients with an erythropoiesis-stimulating agent improves HRQOL.

Topics: Adult; Aged; Anemia; Canada; Data Interpretation, Statistical; Epoetin Alfa; Erythropoietin; Fatigue; Female; Health Status; Hematinics; Humans; Kidney Failure, Chronic; Male; Middle Aged; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Renal Dialysis

Anemia is common among patients with malignant tumors, due to the disease and chemotherapy. Anemia decreases patient's quality of life, and worsens the dose-intensity of chemotherapy. The aim of this retrospective data-analysis was to evaluate quality of life and hemoglobin levels in 19 consecutive lung cancer patients receiving beta-erythropoietin, due to chemotherapy induced anemia. A self developed, patient source data based quality of life questionnaire was used. The mean pre-erythropoietin hemoglobin concentration of the patients was 96.31±6.72 g/L (mean±SD), the post-treatment hemoglobin concentration 111.63±14.05 g/L (p<0.05). During the chemotherapy of the 19 patients with lung cancer, transfusion was given only four times. The mean quality of life total score of the patients increased significantly during erythropoietin treatment that was resulted by the improvements of scores determining dizziness, tachycardia, and fatigue. Main limitations of this real life data analysis are low patient number and the lack of validation in the used questionnaire. In summary, according to our experiences, the use of beta-erythropoietin in patients with lung cancer results improved quality of life and a low rate of transfusions.

Topics: Adult; Aged; Anemia, Hypochromic; Antineoplastic Agents; Blood Transfusion; Dizziness; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Lung Neoplasms; Male; Middle Aged; Quality of Life; Recombinant Proteins; Retrospective Studies; Surveys and Questionnaires; Tachycardia; Treatment Outcome

Cognitive dysfunction is a potential side effect of chemotherapy, and erythropoietin might be protective. A previously reported study compared quality-of-life in women undergoing chemotherapy for breast cancer who were randomized to receive epoetin-alpha or standard care. Here, we report a non-randomized sub-study in which cognitive function of participants was evaluated at 12-30 months after chemotherapy.. The primary endpoint was the proportion of women with moderate-severe cognitive impairment, as measured by the High Sensitivity Cognitive Screen (HSCS). Subjects also completed the Revised Hopkins Verbal Learning Test (HVLT-R), the Functional Assessment of Cancer Therapy--Fatigue (FACT-F) and FACT-G self-report questionnaires for fatigue and quality-of-life, and the Hospital Anxiety and Depression Scale.. Of 278 patients receiving adjuvant treatment in the primary study, 87 participated in the sub-study: 45 had received epoetin-alpha and 42 standard care. Groups were well matched for age and type of chemotherapy. Eight patients (9%) had moderate-severe cognitive dysfunction by the HSCS: six of them in the epoietin-alpha group (not significant). There were no significant differences in the HVLT-R, or in fatigue, but patients who had received epoetin-alpha reported better quality-of-life.. This study failed to demonstrate a protective effect of epoetin-alpha against the development of delayed cognitive dysfunction after chemotherapy.

Topics: Antineoplastic Agents; Breast Neoplasms; Case-Control Studies; Cognition Disorders; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Matched-Pair Analysis; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins

Topics: alpha-Thalassemia; Anemia; Darbepoetin alfa; Erythropoietin; Fatigue; Female; Hematinics; Humans; Pregnancy; Pregnancy Complications, Hematologic; Prenatal Care; Recombinant Proteins

Topics: Activities of Daily Living; Anemia; Antineoplastic Agents; Benzhydryl Compounds; Central Nervous System Stimulants; Counseling; Darbepoetin alfa; Erythropoietin; Exercise; Fatigue; Hematinics; Humans; Meta-Analysis as Topic; Methylphenidate; Modafinil; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Surveys and Questionnaires

The primary aim of this study was to assess whether epoetin alpha (Ea) would improve cognitive performance in a group of anaemic cancer patients receiving chemotherapy. The secondary aim was to confirm the positive impact of Ea on haematological parameters, and quality of life (QOL). Fifty patients with solid tumours and haemoglobin (Hb) <11.0 g/dL received Ea 40,000 units once weekly for 12 weeks and were administered the Mini-Mental State Examination and the European Organization for Research and Treatment of Cancer (QLQ-C30) questionnaire prior to Ea therapy and at study completion. No clinically significant alterations were observed on cognitive function during Ea treatment. Changes in cognitive function were unrelated to Hb change and there were no significant differences in cognitive performance between Ea responders and non-responders. The analyses revealed clinically significant improvements in Hb levels, physical and role function, and clinically meaningful reductions in fatigue. Hb changes were significantly associated with the magnitude of improvement in QOL parameters. The lack of a clinical benefit in cognition observed in this study during Ea treatment may redirect the focus of research from enhancing to maintaining cognitive function, since stability in cognitive performance through time may be as well clinically important.

Topics: Adolescent; Adult; Aged; Anemia; Antineoplastic Agents; Chemotherapy, Adjuvant; Cognition Disorders; Drug Administration Schedule; Epoetin Alfa; Erythropoietin; Fatigue; Female; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Recombinant Proteins; Treatment Outcome; Young Adult

Fatigue is a common complication of adjuvant chemotherapy and compromises the quality of life of breast cancer survivors. We sought to correlate serial hemoglobin (Hb) levels with fatigue in a population of women on adjuvant chemotherapy, none of whom received erythropoietin-stimulating agents or red blood cell transfusions.. Seventy-five women participated in a study using quality-of-life questionnaires to assess changes in need for psychosocial support over time. Questionnaires were administered within 30 days of initiating adjuvant therapy and at 2, 6, and 12 months. Fatigue was assessed by the 36-Item Short-Form Health Survey (SF-36). Hemoglobin levels at each time point were captured retrospectively. Complete data are included for 40 of the 46 women who received adjuvant chemotherapy. Paired-samples t tests were conducted to compare mean SF-36 Energy/Fatigue scores between time points, and independent-samples t tests were conducted for comparisons against norms. Simple correlations (Pearson R) were conducted between SF-36 variables and Hb levels at each time point.. At 2 months, 23.4% of women had Hb<11 g/dL compared with 12.9% at 12 months. Compared with norms for women in the general population and breast cancer survivors, these women reported worse fatigue at baseline and at 2 and 6 months. A strong linear relationship was observed between Hb at 2 months and SF-36 Energy/Fatigue scores at 12 months (r=0.71; P=.002).. Participants with high fatigue at 12 months had Hb levels at 2 months 13% lower than those with low fatigue. This finding suggests that chemotherapy-induced decline in Hb might be a marker of physiologic reserve.

Topics: Adult; Aged; Antineoplastic Agents; Breast Neoplasms; Chemotherapy, Adjuvant; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Middle Aged; Quality of Life; Recombinant Proteins; Surveys and Questionnaires

Despite the clinical importance of health-related quality of life (QOL) in patients suffering from myelodysplastic syndromes (MDS), few data exist on the prevalence of key MDS-associated symptoms, or the correlation of those symptoms with specific disease features such as hemoglobin level. In order to better understand the burden of disease-associated symptoms in patients with MDS, we designed a 120-question Internet-based survey of QOL appropriate for patients with MDS, incorporating validated QOL measurement instruments and questions about specific therapies. The 359 survey respondents were typical of MDS patients in terms of demographics, blood counts, and disease subtype. Patients reported high levels of excessive fatigue and poor scores on QOL assessments such as the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and the Brief Fatigue Inventory (BFI). Patients' debilitating fatigue correlated poorly with hemoglobin level, and fatigue was associated with significant impairment of both health-related QOL and ability to work or participate in desired activities. Within the limitations of self-reported data, these results provide a benchmark for future interventions to improve QOL in patients with MDS.

Topics: Adult; Aged; Aged, 80 and over; Darbepoetin alfa; Epoetin Alfa; Erythropoietin; Exanthema; Fatigue; Female; Hemoglobins; Humans; Male; Middle Aged; Myelodysplastic Syndromes; Quality of Life; Recombinant Proteins

One important side effect from alpha interferon is depression of bone marrow function and studies have shown that patients with carcinoid tumours treated with alpha interferon suffers from fatigue and impaired physical functions. The aim of this pilot study was to investigate if treatment with erythropoietin (EPO) could have a positive effect on self-rated quality of life (QoL). Eighteen patients with midgut carcinoid treated with alpha interferon were included in the study. There were statistical significant increases in haemoglobin (Hb) levels between baseline and 4 months, between baseline and 8 months as well as between baseline and 2-year follow-up. No EPO related side effects were reported. There were improvements of more than 10 points in self-rated QoL-issues related to anaemia. Even though the analysis did not reveal any statistically significant relation between the observed increase in Hb levels and self-rated QoL, this pilot study has increased the knowledge about benefits, doses and frequency of EPO treatment in patients with midgut carcinoid suffering from interferon related anaemia.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Carcinoid Tumor; Erythropoietin; Fatigue; Female; Follow-Up Studies; Gastrointestinal Neoplasms; Hemoglobins; Humans; Interferon-alpha; Male; Middle Aged; Pilot Projects; Quality of Life; Treatment Outcome

Therapy with RBC transfusions and rHuEPO for management of anemia in patients with myelodysplastic syndromes causes recurrent fluctuations in hemoglobin levels. The purpose of this study was to elaborate a mathematical model for the interpretation of hemoglobin fluctuations and to correlate the resulting numerical parameter (Variaglobin Index) with quality of life and fatigue. In 32 myelodysplastic patients, lower amplitude of the Variaglobin Index was found significantly correlated with a better quality of life and less fatigue. The mathematical model proposed here makes it easy to monitor anemia in myelodysplastic patients and to adjust therapy accordingly.

Topics: Aged; Aged, 80 and over; Anemia; Erythrocyte Transfusion; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Male; Middle Aged; Models, Biological; Myelodysplastic Syndromes; Quality of Life; Recombinant Proteins; Software; Surveys and Questionnaires; Treatment Outcome

Epoetin alpha is known to produce a hematological response in anemic cancer patients. A concomitant reduction in fatigue as well as an improvement of depression and anxiety and of quality of life has been reported. However, these effects are discussed controversially. Psychological variables may have a moderating effect on fatigue reduction.. Fifty-four anemic cancer outpatients were treated with epoetin alpha over 26 weeks with an initial dose of 3 x 10,000 IU/week and further individually adapted dosage. Hemoglobin level, fatigue, depression, anxiety, and health-related quality of life were measured every 4 weeks.. The hematological response rate was 50%, with 1/3 occurring after more than 8 weeks of treatment. Fatigue, depression, and quality of life improved significantly. Reduction in fatigue was associated with response, but the correlations between fatigue and hemoglobin were weak. Less depression and higher quality of life before treatment correlated with a better fatigue reduction when controlling for hemoglobin increase and initial fatigue level.. Psychological variables influence the reduction of fatigue during therapy with epoetin alpha in anemic cancer patients and should therefore be assessed at the beginning of treatment.

Topics: Adult; Aged; Anemia; Anxiety; Biomarkers; Case-Control Studies; Depression; Epoetin Alfa; Erythropoietin; Fatigue; Female; Germany; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Predictive Value of Tests; Psychology; Quality of Life; Recombinant Proteins; Surveys and Questionnaires; Time Factors; Treatment Outcome

An anti-anemia drug may improve self-reported quality of life (QOL) partly because patients know their hemoglobin level is rising. In the absence of any published studies on this topic, the authors investigated the association between knowledge of hemoglobin levels and self-reported QOL.. The study analyzed health-related QOL (HRQOL) data from five randomized clinical trials of erythropoietic therapy in patients with cancer-related anemia. Patients were asked whether they knew their hemoglobin level and, if so, to report its value. Patients (n=1007) were grouped into three categories depending on the extent and accuracy of hemoglobin level knowledge. HRQOL scale scores were compared between categories.. Only 23.2% of patients reported knowing their hemoglobin level at the end of the study; however, the value was accurate (within 1 g/dl) in 88.0% of these patients. On five of the 11 HRQOL scales studied, there was a significant association between knowledge of hemoglobin level and HRQOL score. However, the magnitude of the mean difference between those who knew vs. those who did not know their hemoglobin was generally below scale thresholds for minimally important differences.. Patient knowledge of hemoglobin level has a modest association with some aspects of self-reported HRQOL. The magnitude of this association, where it exists, would be unlikely to explain large group differences in HRQOL reports over time, even for patients who know their hemoglobin level.

Topics: Aged; Anemia; Darbepoetin alfa; Epoetin Alfa; Erythropoietin; Fatigue; Female; Health Knowledge, Attitudes, Practice; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Sickness Impact Profile

In a large, 16-week, prospective study of 2,964 anemic patients with various cancers undergoing chemotherapy, once-weekly subcutaneous administration of 40,000 U of epoetin alfa,with potential escalation to 60,000 U, increased hemoglobin (Hgb) levels, decreased transfusion requirements, and improved quality of life (QOL) as assessed using the Linear Analog Scale Assessment (LASA) for energy, activity, and overall QOL and the Functional Assessment in Cancer Therapy-Anemia (FACT-An) QOL instrument. A retrospective subset analysis conducted in 244 colorectal cancer patients enrolled in the study showed statistically significant improvements from baseline to final readings in LASA energy, activity, and overall QOL and FACT-An Anemia Symptoms and Fatigue subscale scores (P < 0.02). Moreover, patients who achieved larger improvements in Hgb levels also demonstrated greater percentage improvements in QOL over baseline measurements. Mean Hgb levels increased by 1.2 g/dL after 4 weeks of treatment and by 1.6 g/dL by study end, independent of red blood cell transfusion within 28 days prior to the Hgb assessment. Hematopoietic response (Hgb level > or = 12 g/dL and/or increase in Hgb level > or = 2 g/dL, independent of transfusion) was observed in 61% of patients (139/229). Additionally, the proportion of patients receiving transfusions decreased from 17% at baseline to 4% during the final month of therapy. Epoetin alfa was well tolerated, with no evidence of unexpected adverse events. Except for significantly higher QOL scores at baseline, results for the cohort of colorectal cancer patients were similar to those for patients with other cancer types in the main study population.

Topics: Adenocarcinoma; Adult; Anemia; Antineoplastic Agents; Clinical Trials as Topic; Colorectal Neoplasms; Epoetin Alfa; Erythropoietin; Fatigue; Hemoglobins; Humans; Quality of Life; Recombinant Proteins; Retrospective Studies

Earlier studies showing a negative impact of anaemia on quality of life (QOL) lack adequate adjustment for confounding factors such as disease stage and tumour response. We examined the impact of haemoglobin concentration on QOL scores of 745 multiple myeloma patients followed from diagnosis, adjusting for objective disease parameters. Data from two Nordic studies with the EORTC QLQ-C30 questionnaire were analysed using linear regression analysis. Haemoglobin was independently related only to fatigue at baseline (P = 0.001) and at 12 months (P = 0.010). In multivariate analysis, extent of skeletal disease was at least as strong a predictor for fatigue at diagnosis as haemoglobin and was also related to other important QOL scores such as physical functioning, role functioning, global QOL and pain (P < 0.001). At 12 months' follow-up, response to therapy was related to physical functioning (P < 0.001) and pain (P = 0.001). In conclusion, haemoglobin and extent of skeletal disease were both predictors for fatigue in patients with newly diagnosed multiple myeloma, but extent of skeletal disease was also associated with other important QOL scores. During follow-up, response to therapy emerged as an important predictor variable. When examining the effect of haemoglobin on QOL, it is essential to adjust for disease parameters and response to therapy in order not to overestimate the impact of haemoglobin on QOL. Our findings imply that uncontrolled studies on the effect of erythropoietin (EPO) in cancer patients may be making exaggerated claims for the effect of EPO on QOL.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Bone Diseases; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Male; Middle Aged; Multiple Myeloma; Neoplasms; Norway; Physical Endurance; Quality of Life; Regression Analysis; Surveys and Questionnaires; Treatment Outcome

Topics: Anemia; Clinical Trials, Phase II as Topic; Darbepoetin alfa; Databases, Factual; Erythropoietin; Fatigue; Hemoglobins; Humans; Myelodysplastic Syndromes

Topics: Anemia; Antineoplastic Agents; Erythropoietin; Fatigue; Hemoglobins; Humans; Neoplasms; Quality of Life; Survival Analysis

Topics: Anemia; Antineoplastic Agents; Depression; Erythropoietin; Fatigue; Humans; Neoplasms; Radiotherapy

Anemia is a common complication associated with cancer and cancer treatment. As many as 50% to 60% of cancer patients will develop this condition. Fatigue is a major symptom of anemia and is a primary complaint in patients with cancer. Fatigue can be debilitating for patients, reducing their ability to work, decreasing physical and emotional well-being, and interfering with cognitive ability, all of which can lead to anxiety and depression. Despite the high incidence of the disease and the extent of its impact on the cancer patient, anemia remains underdiagnosed and undertreated. Erythropoietic proteins offer a valuable alternative to standard transfusion therapy, and there is increasing evidence that, in addition to raising hemoglobin levels, these therapeutic agents can lead to improvements in quality of life and patient-reported outcomes. The impact of anemia correction on survival is under investigation; a body of evidence suggests a possible benefit, although this has recently been challenged. There is a strong need for increased awareness of cancer-related anemia and the consequences of its lack of treatment.

Topics: Anemia; Erythropoietin; Fatigue; Humans; Neoplasms; Quality of Life

Topics: Anemia; Erythropoietin; Fatigue; Humans; Neoplasms; Nursing Assessment; Nursing Diagnosis; Recombinant Proteins; Syndrome

Topics: Anemia; Antineoplastic Agents; Cancer Care Facilities; Erythropoietin; Fatigue; Humans; Neoplasms; Practice Guidelines as Topic

These guidelines propose a treatment algorithm in which patients are evaluated regularly for fatigue using a brief screening instrument, and are treated as indicated by their fatigue level. The algorithm's goal is to identify and treat all patients with fatigue that causes distress or interferes with their daily activities or functioning. Management of fatigue begins with primary oncology team members who perform the initial screening and either provide basic education and counseling or expand the initial screening to a more focused evaluation for moderate or higher levels of fatigue. At this point the patient is assessed for current disease and treatment status, a review of body systems, and an in-depth fatigue evaluation. In addition, the patient is assessed for the presence of seven treatable factors known to contribute to fatigue: pain, emotional distress, sleep disturbance, anemia, alterations in nutrition, deconditioning, and comorbidities. If any of these conditions are present, they should be treated according to practice guidelines, with referral to other care professionals as appropriate, and the patient's fatigue should be reevaluated regularly. If none of the seven factors are present or the fatigue is unresolved, selection of appropriate fatigue management and treatment strategies is considered within the context of the patient's clinical status: receiving active cancer treatment, receiving disease-free long-term follow-up, or receiving care at the end of life. Management of fatigue is cause-specific when conditions known to cause fatigue can be identified and treated. When specific causes, such as infection, fluid and electrolyte imbalances, or cardiac dysfunction, cannot be identified and corrected, nonpharmacologic and pharmacologic treatment of the fatigue should be considered. Nonpharmacologic interventions may include a moderate exercise program to improve functional capacity and activity tolerance, psychosocial programs to manage stress and increase support, restorative therapies to decrease cognitive alterations and improve mood state, and nutritional and sleep interventions for patients with disturbances in eating or sleeping. Pharmacologic therapy may include drugs, such as antidepressants for depression or erythropoietin for anemia. A few clinical reports of the use of psychostimulants suggest the need for further research on these agents as potential treatment modalities in managing fatigue. Effective management of cancer-related

Topics: Antineoplastic Agents; Erythropoietin; Fatigue; Humans; Mass Screening; Neoplasms; Practice Patterns, Physicians'; Quality of Life; United States

Strategies for managing antineoplastic therapy-associated hematopoietic toxicity (thrombocytopenia, neutropenia, and anemia) are discussed. Hemorrhage secondary to decreases in platelets is the major risk posed by chemotherapy-induced thrombocytopenia. Patients with < 20,000 platelets per microliter are at increased risk of bleeding, particularly if they have a history of bleeding associated with this condition. The risks of infection and complications are related to both the severity and duration of neutropenia. The rate of febrile neutropenia with most antineoplastic regimens is < 40%, and routine use of cytokine therapy is probably not cost-effective. The frequency of cancer-related anemia is dependent on the type, stage, and duration of disease. Chemotherapy-induced anemia is affected by the types of agents used, the schedule of drug administration, and the intensity of the regimen. Fatigue is the most common symptom of anemia, being reported by 80-100% of patients undergoing chemotherapy. Although fatigue is a major factor in patients' quality of life, it has often not been treated systematically and aggressively. Anemia used to be treated with transfusions, but therapy with epoetin alfa is showing promise as an alternative. The introduction of epoetin alfa has led to more aggressive treatment. Chemotherapy-induced hematopoietic toxicity is a multifactorial challenge that affects the treatment of oncology patients.

Topics: Anemia; Antineoplastic Agents; Epoetin Alfa; Erythropoietin; Fatigue; Hematinics; Humans; Neutropenia; Practice Guidelines as Topic; Recombinant Proteins; Severity of Illness Index; Thrombocytopenia

Topics: Anxiety; Consumer Product Safety; Drug Industry; Erythropoietin; False Positive Reactions; Fatigue; Humans; Marketing of Health Services; Mass Screening; Neoplasms; Prostate-Specific Antigen; United States; United States Food and Drug Administration; Vaginal Smears

Topics: Anemia; Blood Transfusion; Diet; Erythropoietin; Fatigue; Female; Hemoglobins; Humans; Male; Recombinant Proteins

Dialysis saves lives. However, dialysis alone cannot make those lives active and meaningful. Exercise, in particular, is critical in the rehabilitation of many individuals with chronic renal insufficiency The purpose of this pilot study was to: 1) examine changes in participants' physical capacity and quality of life with the intervention of a 12-week exercise program; 2) investigate whether erythropoietin (EPO) and antihypertensive medication dosages were reduced in the participants; 3) examine the feasibility of incorporating exercise into the London Health Sciences Centre (LHSC) hemodialysis program. A quasi-experimental one-group pre- and post-test design was utilized. Eight subjects completed the 12-week study. The exercise program involved a warm-up, stretching, strengthening, and cardiovascular training. The results demonstrated improvements in the participants'physical capacity, quality of life, and ability to perform activities of daily living (ADLs). There were no discernable trends in the participants' hemoglobin levels or EPO dosages. Although there were no statistically significant changes in participants' blood pressures, five out of the six participants who began the program on antihypertensive medications either had the dosages decreased or the drug(s) discontinued. Data from this small prospective study supports previous research that an exercise during dialysis program is safe and has the potential to result in positive patient outcomes.

Topics: Activities of Daily Living; Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Attitude to Health; Erythropoietin; Exercise Therapy; Fatigue; Feasibility Studies; Female; Hematocrit; Hemoglobins; Humans; Kidney Failure, Chronic; Male; Middle Aged; Nursing Evaluation Research; Ontario; Pilot Projects; Program Evaluation; Prospective Studies; Quality of Life; Renal Dialysis

Lisa Capaldini, a physician who treats patients with HIV-related fatigue, discusses symptoms, diagnosis techniques, and treatments of depression, anemia, and various other roots of fatigue in HIV-positive patients. Biochemical depression, caused by abnormal levels of serotonin and norepinephrine in the brain, is easily misdiagnosed or overlooked. Physical and emotional symptoms of depression mirror common effects of HIV such as exhaustion, anger, and irritability. Knowing the history of depression prior to HIV infection, including previous drug abuse and family history of depression, will help to diagnose fatigue. Dr. Capaldini recommends antidepressants provided the condition is properly diagnosed and the side effects are not harmful to the patient. Selective serotonin reuptake inhibitors (SSRI), the most frequently prescribed antidepressants, can cause short term sexual dysfunction. Bupropion and Wellbutrin can be prescribed to avoid this side effect. Psychotherapy can be effective if therapists are familiar with HIV disease and can distinguish between symptoms brought on by behavior, addictive habits, or pre-existing depression. Consideration also must be given to drug interactions, particularly with the antiretrovirals ritonavir and delavirdine, which can cause seizures or disturb cardiac rhythm. Anemia is most noticeable after physical exertion, and symptoms are more evident based on the increased rate that red blood cells move out of the normal range. To determine the course of treatment, physicians need to clarify the cause of anemia. Anemia can be caused by drugs, vitamin deficiencies, or other nutritional problems. Adrenal insufficiency, methemoglobinemia, and malnutrition are also causes of fatigue. Diagnosing fatigue due to hepatitis B or C, rather than HIV, can be achieved by measuring hepatitis levels and observing T cell counts and viral load. Dr. Capaldini suggests that proper diet and exercise prevent fatigue from getting worse.

Topics: Adrenal Insufficiency; Anemia; Anti-HIV Agents; Antidepressive Agents; Depression; Drug Interactions; Erythropoietin; Fatigue; Female; Hepatitis, Viral, Human; HIV Infections; Humans; Male; Methemoglobinemia; Nutrition Disorders

Attention difficulties and psychomotor slowing associated with depressed mood affect the ability of individuals to perform on most neuropsychological tests. It has been suggested that latency of the P3 (P300) component of the event-related EEG potential is an index of neurocognitive status which is not affected by mood. Dialysis patients, who experience diminished dysphoric mood with the reversal of anemia when treated with recombinant human erythropoietin (rHuEPO), were tested for neurocognitive performance, mood and latency of P3. Prior to rHuEPO treatment mood was dysphoric, and neurocognitive testing showed mild deficits, but P3 latency was normal. After treatment, mood improved and neurocognitive test performance was normal. P3 amplitude increased over frontal areas, while P3 latency remained unchanged. Thus, in the case of dysphoric mood, P3 latency may provide a more accurate index of cognitive capacity (as opposed to level of functioning) than neurocognitive test measures.

Topics: Affect; Anemia; Arousal; Attention; Cerebral Cortex; Depression; Erythropoietin; Evoked Potentials, Auditory; Fatigue; Humans; Kidney Failure, Chronic; Middle Aged; Neurocognitive Disorders; Neuropsychological Tests; Reaction Time; Recombinant Proteins; Renal Dialysis