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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004912 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cachexia Fatigue Unspecified Adult Solid Tumor, Protocol Specific |
Drug: megestrol acetate Procedure: physical therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Phase II Trial of Progressive Resistance Training With Megestrol Acetate for the Treatment of Cancer-Related Weight Loss |
| Study Start Date: | January 2000 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arkansas | |
| University of Arkansas - Department of Geriatrics | |
| North Little Rock, Arkansas, United States, 72114-1706 | |
| United States, California | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| United States, Florida | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Office of David Cella | |
| Evanston, Illinois, United States, 60201 | |
| United States, North Carolina | |
| Rex Healthcare | |
| Raleigh, North Carolina, United States, 27607 | |
| Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Jamie Von Roenn, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004912 History of Changes |
| Other Study ID Numbers: | NU FDA98CC6, NU-98CC6, NCI-G00-1705 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific fatigue cachexia |
|
Cachexia Fatigue Weight Loss Emaciation Body Weight Changes Body Weight Signs and Symptoms Megestrol Acetate Megestrol Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Appetite Stimulants Central Nervous System Stimulants Physiological Effects of Drugs Central Nervous System Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
