Grant Number:	1R03CA103488-01A1 Interpret this number
Primary Investigator:	Visovsky, Constance
Organization:	Case Western Reserve University
Project Title:	Strength Training for Therapy-Induced Muscle Weakness
Fiscal Year:	2004

DESCRIPTION (provided by applicant): Treatments for cancer can have deleterious effects. Both chemotherapy and biotherapy have documented ill effects on skeletal muscle. Cancer and treatment-related side effects such as decreased energy level, muscle weakness and declines in functional status and body mass have been well documented. Early detection methods and novel therapies have increased the life span of individuals living with cancer, and thus, individuals with cancer are living longer lives with the effects of disease and treatment. The purpose of this study is to test the effectiveness of adherence to a strength training exercise program in individuals undergoing chemotherapy for Stage I-IIIa non-metastatic breast cancer. The primary specific aim of this study is to determine the effect of a strength training exercise program on changes in muscle strength, fatigue, body composition and quality of life over time, controlling for age, total drug dose, research site, and baseline muscle strength. A secondary specific aim is to determine the feasibility and acceptability of a home-based strength training exercise program to patients and clinicians. A two group randomized clinical trial will be used for this study, a convenience sample of 128 (64 per group) subjects receiving treatment with chemotherapy will be recruited and data on muscle strength, body composition, fatigue levels and quality of life will be collected at baseline, and 4, 8 and 12 weeks of treatment. Following baseline data collection, subjects will be randomly assigned to the tailored strength training intervention or to the control group. Subjects in the intervention group will be given usual care plus a home strength training exercise program. Participants in the comparison group will receive an attentional intervention in addition to the usual care. Data analysis will compare group differences using ANCOVA and regression slopes calculated as scores of change over time for the dependent variables. Questions regarding the feasibility and acceptability of a home-based strength training exercise program will be collected from the intervention group at protocol completion. Content analysis and quantitative data will be used to determine the feasibility and acceptability of a home-based strength training exercise program to patients and clinicians.





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