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

Phase 2

Completed

• Conditions: Fatigue; Cachexia; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00004912
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2000-03-07
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted QC: 2004-03-02
• Study First Posted: 2004-03-03
• Disposition First Submitted: 2011-02-18
• Disposition First Submitted QC: 2011-02-18
• Disposition First Posted: 2011-02-25
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

University of Arkansas - Department of Geriatrics; 🇺🇸 North Little Rock, Arkansas, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Office of David Cella; 🇺🇸 Evanston, Illinois, United States

Shands Hospital and Clinics, University of Florida; 🇺🇸 Gainesville, Florida, United States

Rex Healthcare; 🇺🇸 Raleigh, North Carolina, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University; 🇺🇸 Chicago, Illinois, United States