A Phase III Randomized Study Comparing The Effects Of Oxandrolone (Oxandrin) And Megestrol Acetate (Megace) On Lean Body Mass, Weight, Body Fat, And Quality Of Life In Patients With Solid Tumors And Weight Loss Receiving Chemotherapy
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Lean body mass as measured by the Bioelectrical Impedance Analysis monthly
1 month intervals
Edward G. Shaw, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Greenville||Greenville, South Carolina 29615|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|Mission Hospitals - Memorial Campus||Asheville, North Carolina 28801|
|Presbyterian Cancer Center at Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Pennington Cancer Center at Baton Rouge General||Baton Rouge, Louisiana 70806|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Moses Cone Regional Cancer Center at Wesley Long Community Hospital||Greensboro, North Carolina 27401|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|Pardee Memorial Hospital||Hendersonville, North Carolina 28791|
|High Point Regional Hospital||High Point, North Carolina 27261|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|Kentuckiana Cancer Institute, PLLC||Louisville, Kentucky 40202|
|Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County||Martinsville, Virginia 24115|
|Helen F. Graham Cancer Center at Christiana Care||Newark, Delaware 19713|
|Southeastern Medical Oncology Center - Goldsboro||Goldsboro, North Carolina 27534|