NCT00004912

Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

Phase II Trial of Progressive Resistance Training With Megestrol Acetate for the Treatment of Cancer-Related Weight Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cachexia
• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	megestrol acetate
PROCEDURE	physical therapy

Timeline

• Start date: 2000-01-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2004-03-03
• Last updated: 2012-05-30

Locations

6 sites across 1 country: United States