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Exercise for Breast Cancer Patients (EXCAP)

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT00851812
Collaborator
National Cancer Institute (NCI) (NIH)
114
Enrollment
1
Location
2
Arms
152.5
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
  • Behavioral: Progressive walking and resistance exercise treatment
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jan 15, 2020
Actual Study Completion Date :
Jan 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Usual Care: Standard care monitoring

Behavioral: Exercise
Standard care monitoring
Other Names:
  • Usual care: standard care monitoring

    		•
    Experimental: Arm 2

    Progressive walking and resistance exercise treatment

    Behavioral: Progressive walking and resistance exercise treatment
    Home-based exercise : Progressive walking and resistance program

    Outcome Measures

    Primary Outcome Measures

    1. Cancer-related fatigue [4.5 months]

    Secondary Outcome Measures

    1. To provide preliminary data on influence of QOL and it's relationship to CRF [4.5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 James P. Wilmot Cancer Center, University of Rochester Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Karen Mustian, Ph.D., James P. Wilmot Cancer Center, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Mustian, Associate Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00851812
    Other Study ID Numbers:
    • 8029NCI
    First Posted:
    Feb 26, 2009
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Karen Mustian, Associate Professor, University of Rochester
    Exercise
    Breast cancer
    fatigue
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Feb 17, 2020