nabilone and Neoplasms

Chemotherapy-induced nausea and vomiting (CINV) is a burdensome adverse event frequently associated with chemotherapy treatment of cancer. Evidence suggests that cannabinoid CB2 receptors are present in brainstem neurons, and thus, there may exist a role for cannabinoids to counter CINV. The aim of this paper is to conduct a systematic review and meta-analysis of the efficacy and safety of oral cannabinoids compared with other treatments as documented in randomized controlled trials (RCTs).. A literature search was conducted using Ovid MEDLINE up until December 31, 2018; Embase Classic and Embase up until 2018 week 53; and Cochrane Central Register of Controlled Trials up until November 2018. Study data were extracted and included in this meta-analysis if they reported on at least one of the following efficacy endpoints: no nausea and no vomiting, no nausea, and no vomiting. The Mantel-Haenszel method and random effects analysis model were used, to generate odds ratio (OR) and accompanying 95% confidence intervals (CI).. In the setting of prophylactic treatment against both nausea and vomiting, oral cannabinoid was more efficacious than placebo or other studied antiemetic treatments. When controlling for vomiting, oral cannabinoid was equally as efficacious as others. Against nausea, oral cannabinoid was equally as effective as other treatments. A greater percentage of patients administered oral cannabinoid for CINV experienced dysphoria, euphoria, and sedation.. Although there exists some evidence suggesting that oral cannabinoids may have a role in controlling for emesis from a neurophysiological perspective, these conclusions are currently not mirrored in the published RCTs to date. However, there exists only a limited number of RCTs, comparisons with older treatment regimens and a lack of standard reporting practice across published literature. Further RCTs should investigate the efficacy and safety of oral cannabinoids, to secure a better picture of the efficacy of oral cannabinoids against CINV.

Topics: Adult; Antiemetics; Antineoplastic Agents; Cannabinoids; Dronabinol; Humans; Induction Chemotherapy; Nausea; Neoplasms; Receptor, Cannabinoid, CB2; Vomiting

Answer questions and earn CME/CNE Marijuana has been used for centuries, and interest in its medicinal properties has been increasing in recent years. Investigations into these medicinal properties has led to the development of cannabinoid pharmaceuticals such as dronabinol, nabilone, and nabiximols. Dronabinol is best studied in the treatment of nausea secondary to cancer chemotherapy and anorexia associated with weight loss in patients with acquired immune deficiency syndrome, and is approved by the US Food and Drug Administration for those indications. Nabilone has been best studied for the treatment of nausea secondary to cancer chemotherapy. There are also limited studies of these drugs for other conditions. Nabiximols is only available in the United States through clinical trials, but is used in Canada and the United Kingdom for the treatment of spasticity secondary to multiple sclerosis and pain. Studies of marijuana have concentrated on nausea, appetite, and pain. This article will review the literature regarding the medical use of marijuana and these cannabinoid pharmaceuticals (with emphasis on indications relevant to oncology), as well as available information regarding adverse effects of marijuana use.

Topics: Analgesics, Non-Narcotic; Antiemetics; Canada; Cannabidiol; Clinical Trials as Topic; Dronabinol; Drug Combinations; Evidence-Based Medicine; Humans; Medical Marijuana; Multiple Sclerosis; Neoplasms; Pain; Treatment Outcome; United Kingdom; United States

To describe the safety and efficacy of nabilone given to pediatric patients to prevent acute chemotherapy-induced nausea and vomiting (CINV).. A multicenter, retrospective review of pediatric patients who received nabilone for acute CINV prophylaxis between December 1, 2010 and August 1, 2015 was undertaken. One course of nabilone was evaluated per patient. Adverse effects associated with nabilone use were noted. The proportion of patients who experienced complete acute chemotherapy-induced vomiting (CIV) control during the acute phase was determined. The acute phase was defined as starting with the first chemotherapy dose and continuing until 24 h after administration of the last chemotherapy dose of the chemotherapy block.. One hundred ten eligible patients (median age: 14.0 years, range: 1.1-18.0 years; 65 male) were identified. Most (109/110) received nabilone plus a 5-HT3 antagonist for CINV prophylaxis. Adverse effects associated with nabilone were experienced by 34% (37/110) of children. All were of CTCAE Version 4.03 Grade 2 or less. Sedation (20.0%), dizziness (10.0%), and euphoria (3.6%) were the most commonly reported adverse events. Nabilone was discontinued in 10 patients due to an adverse event. The proportions of patients receiving highly or moderately emetogenic chemotherapy who experienced complete acute CIV control were 50.6% (42/83) and 53.8% (14/26), respectively.. Adverse events associated with nabilone were common but of minor clinical significance. Acute CIV control in children receiving nabilone as a part of their antiemetic regimen was poor. Future work should focus on implementation of guideline-consistent CINV prophylaxis and treatment.

Topics: Adolescent; Antineoplastic Agents; Child; Child, Preschool; Dronabinol; Female; Humans; Infant; Male; Nausea; Neoplasms; Retrospective Studies; Vomiting

Eighty patients receiving their first course of chemotherapy with regimens containing cisplatin or cisplatin analogues entered this open crossover study comparing nabilone 2 mg and prochlorperazine 5 mg given orally every 12 h for four doses against metoclopramide 2 mg/kg loading dose intravenously (i.v.), then 3 mg/kg as an (i.v.) infusion over 8 h and dexamethasone 20 mg (i.v.) over 3-5 min at the time of chemotherapy. There was complete control of nausea and vomiting in 24 patients (32%) given metoclopramide and dexamethasone compared to 14 patients (19%) given nabilone and prochlorperazine. For the 70 patients who completed the crossover assessment of emesis on a linear analogue scale significantly favoured metoclopramide and dexamethasone (P = 0.02). However, there was no overall patient preference for the metoclopramide and dexamethasone combination (nabilone and prochlorperazine 31 vs. metoclopramide and dexamethasone 26; 13 no preference), because a significant proportion of the patients receiving the cisplatin analogue carboplatin preferred nabilone and prochlorperazine (16 vs. 5; 1 no preference; P = 0.013). For patients receiving cisplatin chemotherapy metoclopramide and dexamethasone remains the antiemetic of choice but for regimens containing carboplatin, nabilone and prochlorperazine is better tolerated and preferred by the patients.

Topics: Adolescent; Adult; Aged; Antiemetics; Cisplatin; Clinical Trials as Topic; Dexamethasone; Dronabinol; Drug Therapy, Combination; Female; Humans; Male; Metoclopramide; Middle Aged; Nausea; Neoplasms; Prochlorperazine; Random Allocation; Vomiting

A randomized, double-blind controlled trial of nabilone versus chlorpromazine was performed in 20 patients with advanced gynaecological cancer who received chemotherapy including cis-platinum. Each patient served as his own control. Nabilone was administered at a dose of 3 mg given orally three times a day, starting the day before cis-platinum and ending the day after. Chlorpromazine was administered at a dose of 12.5 mg given IM, 15 minutes before the start of cis-platinum. Nabilone, in comparison with chlorpromazine did not significantly reduce the number of vomiting. Ten patients preferred nabilone, 5 preferred chlorpromazine and 3 were undecided. Predominant side effects noted by patients were similar for both agents and included somnolence, dry mouth and orthostatic hypotension. No other intervention besides reassurance of the patient was necessary to treat these adverse reactions.

Topics: Adolescent; Adult; Aged; Antiemetics; Chlorpromazine; Cisplatin; Clinical Trials as Topic; Double-Blind Method; Dronabinol; Female; Humans; Middle Aged; Nausea; Neoplasms

The clinical efficacy of antiemetic drugs was tested in cancer patients who were given a placebo and two antiemetic drugs alone and in combination according to random sequences. The method of investigation allowed assessment of the antiemetic effect and side effects of each drug or combination of drugs using a minimum number of patients. The trial design takes into account carry-over effects and biased selection and is potentially useful in the study of drug side effects. Fifteen patients received cyclizine, metoclopramide, cyclizine and metoclopramide, or placebo in a random sequence without evidence that the drugs tested were better than the placebo. A combination of Nabilone and metoclopramide was used in an unrandomized pilot study (prior to the withdrawal of Nabilone from clinical use); these patients recorded better scores for nausea and vomiting and patient acceptability than those in the randomized study. Present antiemetics remain inadequate and although cannabinol derivatives show an improved antiemetic effect, they cause moderate side effects themselves.

Topics: Adolescent; Adult; Aged; Antiemetics; Cisplatin; Cyclizine; Dronabinol; Drug Therapy, Combination; Female; Humans; Male; Metoclopramide; Middle Aged; Nausea; Neoplasms; Pilot Projects; Vomiting

Two double-blind, crossover trials comparing the antiemetic effectiveness of nabilone, a new synthetic cannabinoid, with that of prochlorperazine were conducted in patients with severe nausea and vomiting associated with anticancer chemotherapy. Of 113 patients evaluated, 90 (80 per cent) responded to nabilone therapy, whereas only 36 (32 per cent) responded to prochlorperazine (P less than 0.001). Complete relief of symptoms was infrequent, occurring only in nine patients (8 per cent) given nabilone. When both drugs were compared, both nausea (P less than 0.01) and vomiting episodes (P less than 0.001) were significantly lower in patients given nabilone. Moreover, patients clearly favored nabilone for continued use (P less than 0.001). Predominant side effects noted by patients were similar for both agents and included somnolence, dry mouth and dizziness but were about twice as frequent and more often severe in patients receiving nabilone. In addition, four patients (3 per cent) taking nabilone had side effects (hallucinations in three, hypotension in one) that required medical attention. Euphoria associated with nabilone was infrequent (16 per cent) and mild.

Topics: Adolescent; Adult; Aged; Antiemetics; Antineoplastic Agents; Clinical Trials as Topic; Dronabinol; Drug Evaluation; Female; Humans; Male; Middle Aged; Neoplasms; Prochlorperazine; Vomiting

To estimate prevalence of continuous use (persistence) of prescribed cannabinoid medications for up to 1 year from initial prescription in Manitoba, Canada and predictors of duration of use.. A retrospective, population-based, cohort study using administrative data from the Manitoba Population Research Data Repository located at the Manitoba Centre for Health Policy, Canada.. People without a record of a previous prescription who were prescribed a cannabinoid medication from 1 April 2004 to 1 April 2016 followed for 1 year from the date of first prescription.. Continuous prescribed cannabinoid medication use was defined as use without a gap exceeding 60 days between prescriptions. The primary outcome was prevalence of continuous prescribed cannabinoid medication use for up to 1 year. A secondary outcome was duration of continuous use. Predictors were socio-demographic characteristics, medical diagnoses and type of cannabinoid medication.. Among 5452 new users, 18.1% [95% confidence interval (CI) = 17.08-19.12] were still using cannabinoids at 1 year. Median duration of use was 31 days [interquartile range (IQR) = 25-193]. This was highest for nabilone (33 days, IQR = 25-199) and lowest for nabiximols (20 days, IQR = 7-30). Use was longest among 19-45- and 46-64-year-old users and those with the highest socio-economic status. Fibromyalgia [hazard ratio (HR) = 0.89, 95% CI = 0.84-0.95], osteoarthritis (HR = 0.91, 95% CI = 0.82-0.97) and substance use disorder (HR = 0.85, 95% CI = 0.76-0.94) diagnoses were associated with longer use (HR for discontinuation-HR < 1 less discontinuation and longer use). A diagnosis of cancer was associated with shorter use (HR = 2.73, 95% CI = 2.02-3.67).. In Manitoba, Canada approximately 18% of people prescribed cannabinoid medication continue using for at least 1 year. Duration of use varies with type of cannabinoid medication, age, socio-economic status and dagnosis.

Topics: Adolescent; Adult; Aged; Cannabidiol; Cannabinoids; Dronabinol; Drug Combinations; Duration of Therapy; Female; Fibromyalgia; Humans; Male; Manitoba; Medication Adherence; Middle Aged; Neoplasms; Osteoarthritis; Prescription Drugs; Retrospective Studies; Social Class; Substance-Related Disorders; Young Adult

Topics: Analgesics, Non-Narcotic; Antiemetics; Appetite Stimulants; Cannabinoids; Dronabinol; HIV Infections; Humans; Neoplasms

ABSTRACT Night sweats are one of many symptoms experienced by patients with advanced cancer. The prevalence of night sweats ranges from 10%-48% in cancer patients. Persistent night sweats tend to decrease quality of life through interference with sleep. A recent study has demonstrated that night sweats occur as part of a symptom pattern, and are associated with the anorexia-cachexia symptom cluster. In addition, night sweats represent one of the symptoms that displays a tendency not to improve as patients with advanced cancer approach end of life. This paper serves to report on the successful management of four patients suffering from persistent paraneoplastic night sweats using the synthetic orally administered cannabinoid nabilone. The four patients had been referred to a regional consultative palliative medicine program and identified night sweats as one of their most significant symptomatic concerns reported on their Edmonton Symptom Assessment System (ESAS) questionnaires.

Topics: Aged; Aged, 80 and over; Anti-Anxiety Agents; Dronabinol; Female; Humans; Male; Neoplasms; Palliative Care; Paraneoplastic Syndromes; Sleep Deprivation; Sweating

A prospective observational study assessed the effectiveness of adjuvant nabilone (Cesamet) therapy in managing pain and symptoms experienced by advanced cancer patients. The primary outcomes were the differences between treated and untreated patients at 30 days' follow-up, in Edmonton Symptom Assessment System (ESAS) pain scores, and in total morphine-sulfate-equivalent (MSE) use after adjusting for baseline discrepancies using the propensity-score method. Secondary outcomes included other ESAS parameters and frequency of other drug use. Data from 112 patients (47 treated, 65 untreated) met criteria for analyses.The propensity-adjusted pain scores and total MSE use in nabilone-treated patients were significantly lower than were those found in untreated patients (both P < 0.0001). Other ESAS parameters that improved significantly in patients receiving nabilone were nausea (P < 0.0001), anxiety (P = 0.0284) and overall distress (total ESAS score; P = 0.0208). The nabilone group showed borderline improvement in appetite (P = 0.0516). When compared with those not taking nabilone, patients using this cannabinoid had a lower rate of starting nonsteroidal anti-inflammatory agents, tricyclic antidepressants, gabapentin, dexamethasone, metoclopramide, and ondansetron and a greater tendency to discontinue these drugs.

Topics: Adjuvants, Pharmaceutic; Aged; Aged, 80 and over; Analgesics; Anti-Anxiety Agents; Antiemetics; Cancer Care Facilities; Dronabinol; Female; Humans; Karnofsky Performance Status; Male; Middle Aged; Neoplasms; Pain Measurement; Pain, Intractable; Palliative Care; Prospective Studies; Treatment Outcome

Topics: Antineoplastic Agents; Cannabinoids; Cannabis; Dronabinol; Humans; Nausea; Neoplasms; Vomiting

Nabilone is a cannabinol derivative which has potent central antiemetic effects in animals. We observed that the drug significantly reduced the nausea and vomiting induced by cancer chemotherapy in 10 of 13 patients who were refractory to conventional antiemetics. A dose-response effect was apparent. The drug was generally well-tolerated, although it also had sedative effects. Additionally, dizziness, decreased coordination and postural hypotension were observed in some patients. Euphoric effects of the agent were minimal at antiemetic dosage levels.

Topics: Adolescent; Adult; Aged; Antiemetics; Antineoplastic Agents; Dronabinol; Euphoria; Female; Humans; Male; Middle Aged; Nausea; Neoplasms