Clinical trial NCT00851812: Exercise for Breast Cancer Patients (EXCAP)
Official title: Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Exercise
Breast cancer
fatigue
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-26
Enrollment: 114
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cancer-related fatigue
timeFrame: 4.5 months
Secondary outcomes:
measure: To provide preliminary data on influence of QOL and it's relationship to CRF
timeFrame: 4.5 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center, University of Rochester
state: New York
Study officials:
affiliation: James P. Wilmot Cancer Center, University of Rochester
name: Karen Mustian, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: