Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue
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.
|Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific||Biological: epoetin alfa Procedure: physical therapy||Phase 2|
|Study Design:||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|
|Study Completion Date:||December 2001|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004914
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Jamie Hayden Von Roenn, MD||Robert H. Lurie Cancer Center|