RESUMEN
PURPOSE: The purpose of this study was to measure the effect of megestrol acetate (MA) on weight loss and quality of life (QOL) in patients with cancer of the lung or head and neck undergoing curative radiation therapy. METHODS AND MATERIALS: This was a Phase III, placebo-controlled, double-blind randomized study. Patients received either 800 mg/day of MA (20 milliliters po qAM) or placebo over a 12-week period. Patients received radiation of the head and neck or thorax using a dose of at least 50 Gy, either alone or with chemotherapy. Weight was assessed weekly, whereas QOL was assessed at baseline and at 4, 8, and 12 weeks. RESULTS: Patient characteristics on the MA arm (16 lung, 12 head/neck; mean age: 60 years) were similar to those on the placebo arm (17 lung, 11 head/neck; mean age: 65.8 years). Patients in the MA group had a mean weight loss over 12 weeks of 2.7 pounds, whereas the placebo group had a mean weight loss of 10.6 pounds. There was a significant time by treatment interaction (p = 0.001), with the difference in weight between treatment groups being most pronounced after 6 weeks. Although overall QOL was similar in both arms of the study, several QOL subscale items did differ significantly. Compared to the placebo-treated patients, head-and-neck cancer patients in the MA arm reported the ability to eat as much as they liked (p = 0.02 at 12 weeks), and lung cancer patients in the MA arm reported significantly better appetite at 4 weeks (p = 0.03) and 8 weeks (p = 0.001). CONCLUSION: MA used prophylactically is useful as an appetite stimulant; it can help patients maintain weight over the course of curative radiotherapy of the head and neck or lung and can improve specific aspects of QOL.