Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
NCT00070148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2021-09-09
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.
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Weight Changes
Interventions
- DRUG
-
Megestrol Acetate
Megace by mouth for 12 weeks
- DRUG
-
Oxandrolone 20 mg
20 mg/day for 3 months (12 weeks)
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Edward G. Shaw, MD · Wake Forest University Health Sciences
-
Glenn J. Lesser, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-01
- Primary Completion
- 2007-08-01
- Completion
- 2007-08-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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