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Exercise for Breast Cancer Patients (EXCAP)

Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00851812
Enrollment
114
Registered
2009-02-26
Start date
2007-05-31
Completion date
2020-01-15
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Exercise, Breast cancer, fatigue

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).

Interventions

BEHAVIORALExercise

Standard care monitoring

BEHAVIORALProgressive walking and resistance exercise treatment

Home-based exercise : Progressive walking and resistance program

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Cancer-related fatigue4.5 months

Secondary

MeasureTime frame
To provide preliminary data on influence of QOL and it's relationship to CRF4.5 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026