Effect of megestrol acetate, cyproheptadine, and their combination on appetite, body weight and quality of life (QOL) in cancer patients: A double-blind placebo-controlled clinical trial

Abstract

8141 Background: This study aimed to evaluate effect of progestinal agent and cyproheptadine on Anorexia-cachexia syndrome and QOL in cancer patients. Methods:This study is a double-blind placebo-controlled clinical trial. Eligible cases were non-hormone dependent cancer patients with history of appetite loss or significant weight loss (> 5%) between ages 18–75 years who completed informed consent. Patients stratified according to: 1) >5%below IBW / IBW ± 5% or >5% above IBW 2) Complete or Partial response / stable or progressive disease 3) Cisplatin / Non-Cisplatin based chemotherapy and assigned (by minimization method) to four treatment arms: Megestrol Acetate (320mg/d, BID) + Placebo (MP), Cyproheptadine (8mg/d, BID) + Placebo (CP), Megestrol Acetate + Cyproheptadine (MC) and Placebo + Placebo (PP) for a period of one month. QOL evaluated by EORTC-QLQ-C30 for cancer studies. Results: During 1999 to 2003, 161 cancer patients included and 98 cases (60.9%) completed treatment period (85.4 % in stages III - IV). During study, 75.6 % of cases received chemotherapy and 6 % undergone radiation. Stratified parameters were balanced between treatment arms. Appetite, body weight and QOL changes evaluated at entrance and after one month that their results are summarized in the table below. Conclusions: Appetite and body weight improvements occurred at most in megestrol acetate treatment group (MP) but its difference with other groups was not significant. QOL parameters were not different between treatment arms (P values > 0.05). Considering the short treatment period and difficulties in follow-up of end-stage cancer patients, qualified large-scale clinical trials is needed for defining therapeutic role of these medications. No significant financial relationships to disclose.