ascorbic-acid and Cachexia

Topics: Anorexia; Ascorbic Acid; Cachexia; Drug-Related Side Effects and Adverse Reactions; Enteral Nutrition; Female; Humans; Lipid Metabolism; Male; Minerals; Neoplasms; Nutrition Disorders; Parenteral Nutrition; Pyridoxine; Serum Albumin; Taste Disorders; Thiamine; Vitamin A

In April 2005 a phase III randomized study was started to establish which was the most effective and safest treatment of cancer-related anorexia/cachexia syndrome and oxidative stress in improving identified primary endpoints: increase of lean body mass, decrease of resting energy expenditure (REE), increase of total daily physical activity, decrease of interleukin-6 and tumor necrosis factor-alpha, and improvement of fatigue assessed by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF).. All patients were given as basic treatment polyphenols plus antioxidant agents alpha-lipoic acid, carbocysteine, and vitamins A, C, and E, all orally. Patients were then randomized to one of the following five arms: 1) medroxyprogesterone acetate/megestrol acetate; 2) pharmacologic nutritional support containing eicosapentaenoic acid; 3) L-carnitine; 4) thalidomide; or 5) medroxyprogesterone acetate/megestrol acetate plus pharmacologic nutritional support plus L-carnitine plus thalidomide. Treatment duration was 4 mo. The sample comprised 475 patients.. By January 2007, 125 patients, well balanced for all clinical characteristics, were included. No severe side effects were observed. As for efficacy, an interim analysis on 125 patients showed an improvement of at least one primary endpoint in arms 3, 4, and 5, whereas arm 2 showed a significant worsening of lean body mass, REE, and MFSI-SF. Analysis of variance comparing the change of primary endpoints between arms showed a significant improvement of REE in favor of arm 5 versus arm 2 and a significant improvement of MFSI-SF in favor of arms 1, 3, and 5 versus arm 2. A significant inferiority of arm 2 versus arms 3, 4, and 5 for the primary endpoints lean body mass, REE, and MFSI-SF was observed on the basis of t test for changes.. The interim results obtained thus far seem to suggest that the most effective treatment for cancer-related anorexia/cachexia syndrome and oxidative stress should be a combination regimen. The study is still in progress and the final results should confirm these data.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Antioxidants; Appetite Stimulants; Ascorbic Acid; Basal Metabolism; Cachexia; Carnitine; Dietary Supplements; Exercise; Fatigue; Female; Humans; Interleukin-6; Male; Medroxyprogesterone Acetate; Megestrol Acetate; Middle Aged; Muscle Proteins; Neoplasms; Nutritional Support; Oxidative Stress; Treatment Outcome; Tumor Necrosis Factor-alpha; Vitamin A; Vitamin E

To test the efficacy and safety of an integrated treatment based on a pharmaconutritional support, antioxidants, and drugs, all given orally, in a population of advanced cancer patients with cancer-related anorexia/cachexia and oxidative stress.. An open early-phase II study was designed according to the Simon two-stage design. The integrated treatment consisted of diet with high polyphenols content (400 mg), antioxidant treatment (300 mg/d alpha-lipoic acid + 2.7 g/d carbocysteine lysine salt + 400 mg/d vitamin E + 30,000 IU/d vitamin A + 500 mg/d vitamin C), and pharmaconutritional support enriched with 2 cans per day (n-3)-PUFA (eicosapentaenoic acid and docosahexaenoic acid), 500 mg/d medroxyprogesterone acetate, and 200 mg/d selective cyclooxygenase-2 inhibitor celecoxib. The treatment duration was 4 months. The following variables were evaluated: (a) clinical (Eastern Cooperative Oncology Group performance status); (b) nutritional [lean body mass (LBM), appetite, and resting energy expenditure]; (c) laboratory [proinflammatory cytokines and leptin, reactive oxygen species (ROS) and antioxidant enzymes]; (d) quality of life (European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D, and MFSI-SF).. From July 2002 to January 2005, 44 patients were enrolled. Of these, 39 completed the treatment and were assessable. Body weight increased significantly from baseline as did LBM and appetite. There was an important decrease of proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha, and a negative relationship worthy of note was only found between LBM and IL-6 changes. As for quality of life evaluation, there was a marked improvement in the European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D(VAS), and multidimensional fatigue symptom inventory-short form scores. At the end of the study, 22 of the 39 patients were "responders" or "high responders." The minimum required was 21; therefore, the treatment was effective and more importantly was shown to be safe.. The efficacy and safety of the treatment have been shown by the study; therefore, a randomized phase III study is warranted.

Topics: Adult; Aged; Anorexia; Ascorbic Acid; Cachexia; Carbocysteine; Celecoxib; Dietary Supplements; Docosahexaenoic Acids; Female; Humans; Linear Models; Male; Medroxyprogesterone; Middle Aged; Neoplasms; Nutritional Support; Oxidative Stress; Pyrazoles; Statistics, Nonparametric; Sulfonamides; Thioctic Acid; Treatment Outcome; Vitamin A; Vitamin E

Topics: Activities of Daily Living; Aged; Aging; Ascorbic Acid; Cachexia; Central Nervous System Diseases; Depression; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Paresthesia; Placebos; Pyridoxine; Riboflavin; Theobromine; Thiamine; Vitamin A; Vitamin E; Vitamins

Several major factors may influence the micronutrient requirements of the patient with cancer. These factors include the metabolic state of the malignancy and its effects on host metabolism, the catabolic effects of antineoplastic therapy, and other physiologic stresses commonly associated with the treatment of cancer, i.e., surgery, fever and infection. Although the nutritional importance of vitamins, minerals and trace elements is recognized, the optimal daily dose that will preserve lean body mass without enhancing tumor growth, is not known. Recommended Dietary Allowances (RDAs), where established, are based on populations with nonmalignant diseases. However, supplementation with vitamins, minerals, and certain trace elements is recommended for the cancer patient who requires prolonged parenteral support, since clinically relevant deficiency states have been described. The effect of malignancy on the metabolism of several of these micronutrients (iron, ascorbic acid, alpha tocopherol, selenium, zinc, copper) is discussed.

Topics: Adult; Antineoplastic Agents; Ascorbic Acid; Cachexia; Child; Copper; Female; Humans; Iron; Male; Minerals; Neoplasms; Nutritional Requirements; Parenteral Nutrition; Selenium; Trace Elements; United States; United States Food and Drug Administration; Vitamin E; Vitamins; Zinc

Topics: Adolescent; Adult; Aged; Anemia; Ascorbic Acid; Cachexia; Child; Female; Herpes Zoster; Humans; Liver Diseases; Male; Middle Aged; Neuralgia; Neuritis; Vascular Diseases; Vitamin B Complex

Topics: Ascorbic Acid; Body Fluids; Cachexia; Endotoxins; Glucuronates; Iron; Iron-Dextran Complex; Liver; Metabolism; Neoplasms; Nitrogen; Pharmacology; Urine