Overview

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

Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Megestrol
Megestrol Acetate
Criteria
DISEASE CHARACTERISTICS: Advanced nonhormone responsive malignancy (metastatic or
incurable) Nonvolitional weight loss of between 6-9% of usual body weight over past 6
months OR Decrease of 5 pounds in the past 2 months or less (not greater than 10% loss of
usual body weight) No clinical or radiologic evidence of ascites or pleural effusion No
lytic bone metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: At
least 4 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Cardiovascular: No venous thrombosis No congestive heart failure Other: Able to participate
in exercise program for 1 hour, 3 times/week No physical handicap that precludes aerobic or
resistance exercise No clinical abnormality that renders exercise a risk At least 1 month
since strength training of 3 hours or more per week No physical or functional obstruction
to food intake No uncontrolled emesis greater than 5 episodes/week No diarrhea greater than
4 stools/day intractable to antidiarrheal medication No IV hyperalimentation No
contraindications to megestrol No dementia or mental incompetence No known AIDS Not
pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent adrenal steroids (other than for replacement), anabolics,
appetite stimulants, or progestational agents Intermittent corticosteroids as antiemetic or
premedication for cancer treatment allowed At least 6 weeks since prior megestrol
Radiotherapy: Not specified Surgery: Not specified