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document
Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia : a North Central Cancer Treatment Group study . PURPOSE To determine whether dronabinol administered alone or with megestrol acetate was more , less , or equal in efficacy to single-agent megestrol acetate for palliating cancer-associated anorexia . PATIENTS AND METHODS Four hundred sixty-nine assessable advanced cancer patients were randomized to ( 1 ) oral megestrol acetate 800 mg/d liquid suspension plus placebo , ( 2 ) oral dronabinol 2.5 mg twice a day plus placebo , or ( 3 ) both agents . Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight . RESULTS Groups were comparable at baseline in age , sex , tumor type , weight loss , and performance status . A greater percentage of megestrol acetate-treated patients reported appetite improvement and weight gain compared with dronabinol-treated patients : 75 % versus 49 % ( P =.0001 ) for appetite and 11 % versus 3 % ( P =.02 ) for > or = 10 % baseline weight gain . Combination treatment resulted in no significant differences in appetite or weight compared with megestrol acetate alone . The Functional Assessment of Anorexia/Cachexia Therapy questionnaire , which emphasizes anorexia-related questions , demonstrated an improvement in quality of life ( QOL ) among megestrol acetate-treated and combination-treated patients . The single-item Uniscale , a global QOL instrument , found comparable scores . Toxicity was also comparable , with the exception of an increased incidence of impotence among men who received megestrol acetate . CONCLUSION In the doses and schedules we studied , megestrol acetate provided superior anorexia palliation among advanced cancer patients compared with dronabinol alone . Combination therapy did not appear to confer additional benefit .
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Intervention_Pharmacological
Dronabinol
7839
Intervention_Pharmacological
megestrol acetate versus combination therapy
7840
Intervention_Pharmacological
dronabinol
7841
Intervention_Pharmacological
megestrol acetate
7842
Intervention_Pharmacological
megestrol acetate
7843
Intervention_Pharmacological
megestrol acetate
7844
Intervention_Pharmacological
liquid suspension
7845
Intervention_Control
plus placebo
7846
Intervention_Pharmacological
dronabinol
7847
Intervention_Control
placebo
7848
Intervention_Pharmacological
megestrol acetate-treated
7849
Intervention_Pharmacological
dronabinol-treated
7850
Intervention_Pharmacological
megestrol acetate
7851
Intervention_Pharmacological
megestrol acetate-treated
7852
Intervention_Pharmacological
megestrol acetate
7853
Intervention_Pharmacological
megestrol acetate
7854
Intervention_Pharmacological
dronabinol
7855
Outcome_Physical
appetite improvement and weight gain
7856
Outcome_Physical
differences in appetite or weight
7857
Outcome_Other
quality of life ( QOL )
7858
Outcome_Other
QOL
7859
Outcome_Adverse-effects
Toxicity
7860
Outcome_Physical
impotence
7861
Participant_Sample-size
Four hundred sixty-nine
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Participant_Condition
Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight
7863
Participant_Sex
men