Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

OBJECTIVES: * To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma. * To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma. OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks. * Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks. Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires. Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay. After completion of study treatment, patients are followed periodically for 1 year.