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

Phase 2
18 Years
Not Enrolling
Cachexia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Jamie Hayden Von Roenn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

November 2003

Related Keywords:

  • Cachexia
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • fatigue
  • cachexia
  • Cachexia
  • Fatigue
  • Weight Loss



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Rex Healthcare Raleigh, North Carolina  27607
Pacific Shores Medical Group Long Beach, California  90813
University of Arkansas - Department of Geriatrics North Little Rock, Arkansas  72114-1706
Office of David Cella Evanston, Illinois  60201