This trial is active, not recruiting.

Condition fatigue
Treatments exercise, progressive walking and resistance exercise treatment
Sponsor University of Rochester
Collaborator National Cancer Institute (NCI)
Start date May 2007
End date April 2016
Trial size 114 participants
Trial identifier NCT00851812, 8029NCI


The purpose of this study is to examine if exercise helps improve cancer-related fatigue.

Hypothesis: A structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Usual Care: Standard care monitoring
exercise Usual care: standard care monitoring
Standard care monitoring
Progressive walking and resistance exercise treatment
progressive walking and resistance exercise treatment
Home-based exercise : Progressive walking and resistance program

Primary Outcomes

Cancer-related fatigue
time frame: 4.5 months

Secondary Outcomes

To provide preliminary data on influence of QOL and it's relationship to CRF
time frame: 4.5 months

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Have a primary diagnosis of breast cancer, - Have a functional capacity rating of 60 or greater on the Karnofsky Performance Scale, when assessed by the oncologist (or physician's designee) - Be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). Have a life expectancy of >1 year as determined by the patient's oncologist. - Have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program. - Be able to read English. - Be 21 years of age or older. - Give informed consent. Exclusion Criteria: - Have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis. - Have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the PAR-Q and radiation oncologist (or physician's designee) - Be identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form.

Additional Information

Official title Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue
Principal investigator Karen Mustian, Ph.D.
Description Fatigue is a frequently reported side effect of cancer treatment. Fatigue related to cancer and its treatment is different from fatigue occurring in other situations and its specific causes have not been identified. Exercise may or may not improve this type of fatigue. The purpose of this study is to examine how cancer treatments impact normal lifestyle physical activity patterns and participation in physical activity, as well as the ability of a walking and progressive resistance exercise program to reduce cancer-related fatigue in breast cancer patients. This study also examines if the walking and progressive resistance exercise program improves other factors such as quality of life, depression, anxiety, ability to sleep, self esteem, cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and immune function (as measured by inflammatory cytokines).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Rochester.