Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
RATIONALE: Megestrol helps improve appetite. Exercise may decrease cancer-related fatigue, improve strength, and build up lost muscle tissue. Exercise plus megestrol may be effective treatment for cancer-related weight loss.
PURPOSE: Phase II trial to study the effectiveness of megestrol plus exercise to improve appetite, increase strength, gain lean body tissue, and decrease fatigue in patients who have cancer-related weight loss.
|Cachexia Fatigue Unspecified Adult Solid Tumor, Protocol Specific||Drug: megestrol acetate Procedure: physical therapy||Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Phase II Trial of Progressive Resistance Training With Megestrol Acetate for the Treatment of Cancer-Related Weight Loss|
|Study Start Date:||January 2000|
|Study Completion Date:||November 2003|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the effect of megestrol and progressive resistance training on lean body mass, total body weight, functional capacity, appetite, and fatigue in patients with weight loss due to advanced malignancy.
OUTLINE: This is a multicenter study. Patients receive oral megestrol once daily. Patients also begin progressive resistance training 3 days a week. Treatment/exercise continues for 12 weeks in the absence of unacceptable toxicity or progressive weight loss (greater than 5 pounds or 5% or more over first 4 study weeks).
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004912
|United States, Arkansas|
|University of Arkansas - Department of Geriatrics|
|North Little Rock, Arkansas, United States, 72114-1706|
|United States, California|
|Pacific Shores Medical Group|
|Long Beach, California, United States, 90813|
|United States, Florida|
|Shands Hospital and Clinics, University of Florida|
|Gainesville, Florida, United States, 32610-100277|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Office of David Cella|
|Evanston, Illinois, United States, 60201|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27607|
|Study Chair:||Jamie Hayden Von Roenn, MD||Robert H. Lurie Cancer Center|