Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004914
Recruitment Status : Completed
First Posted : March 4, 2004
Last Update Posted : June 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Exercise may decrease anemia-related fatigue, improve strength, and build up lost muscle tissue. Epoetin alfa may help improve cancer-related anemia, energy levels, and quality of life. Exercise plus epoetin alfa may be effective treatment for anemia-related fatigue.

PURPOSE: Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue.

Condition or disease Intervention/treatment Phase
Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific Biological: epoetin alfa Procedure: physical therapy Phase 2

Detailed Description:

OBJECTIVES: I. Determine the effect of progressive resistance training and epoetin alfa on lean body mass, fatigue, exercise tolerance, functional capacity, and total body weight in cancer patients with anemia related fatigue.

OUTLINE: Patients undergo progressive resistance training (PRT) consisting of 3 sets of 8 repetitions of concentric (lifting) and eccentric (lowering) exercises over 4-6 seconds each using bench press, arm pull, knee extension, knee flexion, and double leg press followed by 1-2 minutes of rest between sets. Patients undergo warm up and cool down periods over 10 minutes prior to and following PRT. Patients perform PRT 3 times a week for 12 weeks. Patients also receive epoetin alfa subcutaneously once weekly over 4-12 weeks in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 15 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: A Phase II Trial of Progressive Resistance Training (PRT) Plus Procrit for the Treatment of Anemia-Related Fatigue in Cancer Patients
Study Start Date : January 2000
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Fatigue
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Diagnosis of nonmyeloid malignancy with cancer related fatigue Anemia (hemoglobin less than 10 g/dL) No clinical or radiographic evidence of lytic bone metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No dementia or evidence of mental incompetence No physical handicap precluding aerobic or resistance exercise No clinical abnormality that would render exercise a risk HIV negative No contraindications to epoetin alfa Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior epoetin alfa Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: Not specified Other: Concurrent anticancer therapy allowed At least 1 month since prior strength training of greater than 3 hours a week

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004914

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University Identifier: NCT00004914     History of Changes
Other Study ID Numbers: NU 98CC7
First Posted: March 4, 2004    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Hematologic Diseases
Signs and Symptoms
Epoetin Alfa