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.

Condition	Treatment or Intervention	Phase
Cachexia unspecified adult solid tumor, protocol specific Fatigue	Drug: megestrol	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arkansas
      University of Arkansas - Department of Geriatrics, North Little Rock,  Arkansas,  72114-1706,  United States
California
      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States
Florida
      Shands Hospital and Clinics, University of Florida, Gainesville,  Florida,  32610-100277,  United States
Illinois
      Office of David Cella, Evanston,  Illinois,  60201,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
North Carolina
      Rex Healthcare, Raleigh,  North Carolina,  27607,  United States

Study chairs or principal investigators

Jamie Hayden Von Roenn,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067592; NU-98CC6; NCI-G00-1705
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004912
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08