RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors. PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.
OBJECTIVES: * Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol. * Compare the health-related quality of life of patients treated with these drugs. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral oxandrolone twice daily. * Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity. Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 62-155 patients (31-77 per treatment arm) will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
155
Megace by mouth for 12 weeks
20 mg/day for 3 months (12 weeks)
Helen F. Graham Cancer Center at Christiana Care
Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States
...and 10 more locations
Lean body mass as measured by the Bioelectrical Impedance Analysis monthly
Time frame: 1 month intervals
Weight
Time frame: 1 month intervals
Body fat as measured by the Bioelectrical Impedance Analysis monthly
Time frame: one month intervals
Health-related quality of life as measured by the Functional Assessment of Cancer Therapy with subscales for anorexia/cachexia and fatigue
Time frame: one month intervals
Performance status as measured by ECOG criteria
Time frame: one month intervals
Toxicity as measured by standard NCI toxicity criteria
Time frame: one month interval
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