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Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

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ClinicalTrials.gov Identifier: NCT00004912
Recruitment Status : Completed
First Posted : March 3, 2004
Last Update Posted : May 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cachexia Fatigue Unspecified Adult Solid Tumor, Protocol Specific Drug: megestrol acetate Procedure: physical therapy Phase 2

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004912


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
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
More Information
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004912     History of Changes
Other Study ID Numbers: NU FDA98CC6
NU-98CC6
NCI-G00-1705
First Posted: March 3, 2004    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Northwestern University:
unspecified adult solid tumor, protocol specific
fatigue
cachexia

Additional relevant MeSH terms:
Weight Loss
Fatigue
Cachexia
Wasting Syndrome
Body Weight Changes
Body Weight
Signs and Symptoms
Emaciation
Metabolic Diseases
Nutrition Disorders
Megestrol
 Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants