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

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
Cancer-Related Problem/Condition Fatigue Unspecified Adult Solid Tumor, Protocol Specific	Drug: megestrol acetate Procedure: physical therapy	Phase II

MedlinePlus related topics:

Cancer Exercise and Physical Fitness Weight Control

Drug Information available for:

Megestrol acetate Megestrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
	Office of David Cella
	Evanston, Illinois, United States, 60201
	Robert H. Lurie Comprehensive Cancer Center, Northwestern University
	Chicago, Illinois, United States, 60611-3013

United States, North Carolina
	Rex Healthcare
	Raleigh, North Carolina, United States, 27607

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators


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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000067592, NU-98CC6, NCI-G00-1705
First Received:	March 7, 2000
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00004912
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

fatigue

cachexia

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Fatigue

Weight Loss

Body Weight Changes

Cachexia

Megestrol

Megestrol Acetate

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Contraceptive Agents

Physiological Effects of Drugs

Contraceptives, Oral

Contraceptive Agents, Female

Central Nervous System Stimulants

Reproductive Control Agents

Pharmacologic Actions

Therapeutic Uses

Contraceptives, Oral, Synthetic

Central Nervous System Agents

Appetite Stimulants

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004912