Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

OBJECTIVES: * Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy. * Determine whether health-related quality of life improves in patients treated with megestrol. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment arms. * Arm I: Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy. * Arm II: Patients receive oral placebo daily according to the schedule for megestrol in arm I. Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8, 12, and 16 weeks after completion of radiotherapy. PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study within 14 months.