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Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss Clinical research trials and Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss clinical trial. Human subjects often receive the most effective healthcare possible for their Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss  Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
For Condition: Fatigue,Cachexia,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamieVon Roenn, Study Chair, Robert H. Lurie Cancer Center
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
Rex Healthcare
Raleigh, North Carolina, 27607
United States
University of Arkansas - Department of Geriatrics
Little Rock, Arkansas, 72114-1706
United States
Pacific Shores Medical Group
Long Beach, California, 90813
United States
Office of David Cella
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000067592; NU-98CC6,NCI-G00-1705
Study Start Date: January 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004912
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
2. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
3. Darbepoetin Alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
4. Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
5. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
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Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
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