Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
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.
|Unspecified Adult Solid Tumor, Protocol Specific Weight Changes||Drug: Megestrol Acetate Drug: Oxandrolone 20 mg||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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|
- 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 ]
|Study Start Date:||March 2004|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1 Oxandrolone 20 mg daily
Oxandrolone 20 mg (10 mg BID) for 12 weeks. 4 additional weeks of follow-up.
Drug: Oxandrolone 20 mg
20 mg/day for 3 months (12 weeks)
Active Comparator: Megace 800 mg
Megestrol acetate 800 mg daily for 12 weeks. 4 additional weeks of follow-up.
Drug: Megestrol Acetate
Megace by mouth for 12 weeks
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070148
|United States, Delaware|
|Helen F. Graham Cancer Center at Christiana Care|
|Newark, Delaware, United States, 19713|
|United States, Florida|
|CCOP - Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Kentucky|
|Kentuckiana Cancer Institute, PLLC|
|Louisville, Kentucky, United States, 40202|
|United States, Louisiana|
|Pennington Cancer Center at Baton Rouge General|
|Baton Rouge, Louisiana, United States, 70806|
|MBCCOP - LSU Health Sciences Center|
|New Orleans, Louisiana, United States, 70118|
|United States, North Carolina|
|Mission Hospitals - Memorial Campus|
|Asheville, North Carolina, United States, 28801|
|Alamance Cancer Center at Alamance Regional Medical Center|
|Burlington, North Carolina, United States, 27216|
|Presbyterian Cancer Center at Presbyterian Hospital|
|Charlotte, North Carolina, United States, 28233-3549|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|Southeastern Medical Oncology Center - Goldsboro|
|Goldsboro, North Carolina, United States, 27534|
|Moses Cone Regional Cancer Center at Wesley Long Community Hospital|
|Greensboro, North Carolina, United States, 27403-1198|
|Leo W. Jenkins Cancer Center at ECU Medical School|
|Greenville, North Carolina, United States, 27835-6028|
|Pardee Memorial Hospital|
|Hendersonville, North Carolina, United States, 28791|
|High Point Regional Hospital|
|High Point, North Carolina, United States, 27261|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43215|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Virginia|
|Danville Regional Medical Center|
|Danville, Virginia, United States, 24541|
|Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County|
|Martinsville, Virginia, United States, 24115-4788|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|
|Principal Investigator:||Glenn J. Lesser, MD||Wake Forest University Health Sciences|