Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cachexia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: megestrol acetate (Drug); physical therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Jamie Hayden Von Roenn, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center
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.
Clinical Details
Official title: Phase II Trial of Progressive Resistance Training With Megestrol Acetate for the Treatment of Cancer-Related Weight Loss
Study design: Primary Purpose: Supportive Care
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Arkansas - Department of Geriatrics, North Little Rock, Arkansas 72114-1706, United States
Pacific Shores Medical Group, Long Beach, California 90813, United States
Shands Hospital and Clinics, University of Florida, Gainesville, Florida 32610-100277, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611-3013, United States
Office of David Cella, Evanston, Illinois 60201, United States
Rex Healthcare, Raleigh, North Carolina 27607, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2000
Last updated: May 17, 2012
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