Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
- Conditions
- Weight ChangesUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00070148
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Megace 800 mg Megestrol Acetate Megestrol acetate 800 mg daily for 12 weeks. 4 additional weeks of follow-up. Arm 1 Oxandrolone 20 mg daily Oxandrolone 20 mg Oxandrolone 20 mg (10 mg BID) for 12 weeks. 4 additional weeks of follow-up.
- Primary Outcome Measures
Name Time Method Lean body mass as measured by the Bioelectrical Impedance Analysis monthly 1 month intervals
- Secondary Outcome Measures
Name Time Method Weight 1 month intervals Body fat as measured by the Bioelectrical Impedance Analysis monthly one month intervals Toxicity as measured by standard NCI toxicity criteria one month interval Health-related quality of life as measured by the Functional Assessment of Cancer Therapy with subscales for anorexia/cachexia and fatigue one month intervals Performance status as measured by ECOG criteria one month intervals
Trial Locations
- Locations (20)
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Alamance Cancer Center at Alamance Regional Medical Center
🇺🇸Burlington, North Carolina, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
🇺🇸Greensboro, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
🇺🇸Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
High Point Regional Hospital
🇺🇸High Point, North Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Pennington Cancer Center at Baton Rouge General
🇺🇸Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Helen F. Graham Cancer Center at Christiana Care
🇺🇸Newark, Delaware, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Kentuckiana Cancer Institute, PLLC
🇺🇸Louisville, Kentucky, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States