Exercise for Breast Cancer Patients (EXCAP)
February 13, 2020 updated by: Karen Mustian, University of Rochester
Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue
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.
Study Overview
Status
Completed
Conditions
Intervention / 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).
Study Type
Interventional
Enrollment (Anticipated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center, University of Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
Usual Care: Standard care monitoring
|
Standard care monitoring
Other Names:
|
|
Experimental: Arm 2
Progressive walking and resistance exercise treatment
|
Home-based exercise : Progressive walking and resistance program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cancer-related fatigue
Time Frame: 4.5 months
|
4.5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To provide preliminary data on influence of QOL and it's relationship to CRF
Time Frame: 4.5 months
|
4.5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Mustian, Ph.D., James P. Wilmot Cancer Center, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
January 15, 2020
Study Completion (Actual)
January 15, 2020
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 25, 2009
First Posted (Estimate)
February 26, 2009
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8029NCI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.