Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/2/2018 |
| Start Date: | October 2015 |
| End Date: | December 2019 |
| Contact: | Kirsten A Nyrop, PhD |
| Email: | knyrop@med.unc.edu |
| Phone: | 919/962-5139 |
Metastatic breast cancer (MBC) is an incurable disease. Maintaining optimum quality of life
is a major goal of care. There is a strong body of evidence that exercise can reduce or
manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base
is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a
home-based, self-directed walking program can have similar benefits in women with an MBC
diagnosis. The primary objective is to evaluate whether engagement in physical activity will
reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary
endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study
participants and measuring changes between baseline, 3 months and 6 months in additional
quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and
sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30
patients. Findings from this study will provide preliminary data for a grant application to
test the physical activity intervention in a randomized controlled trial (RCT) in a large
sample of women with metastatic breast cancer.
is a major goal of care. There is a strong body of evidence that exercise can reduce or
manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base
is overwhelmingly in early stage cancer patients. The purpose of this study is to see if a
home-based, self-directed walking program can have similar benefits in women with an MBC
diagnosis. The primary objective is to evaluate whether engagement in physical activity will
reduce fatigue during active treatment for MBC (baseline to 3 months); this is the primary
endpoint. Secondary objectives pertain to feasibility of recruitment and retention of study
participants and measuring changes between baseline, 3 months and 6 months in additional
quality of life measures. Exploratory analyses pertain to changes in p16INK4a levels and
sarcopenia between baseline and 3 months. The design is a single arm intervention trial in 30
patients. Findings from this study will provide preliminary data for a grant application to
test the physical activity intervention in a randomized controlled trial (RCT) in a large
sample of women with metastatic breast cancer.
Inclusion Criteria:
- Female
- Age 21 or older
- Metastatic breast cancer (MBC) diagnosis - Stage IV
- Receiving treatment regimen for MBC, but no more than 3 previous chemotherapy or
biologic regimens
- Approval from the treating clinician to engage in moderate-intensity physical
activity.
- Patient-assessed ability to walk and engage in moderate physical activity
- Proficient in English.
- IRB approved signed written informed consent.
- Willing and able to do all study requirements.
Exclusion Criteria:
- One or more significant medical conditions or other issues that in the physician's
judgment preclude participation in the walking intervention.
- No more than 3 prior chemotherapy regimens.
We found this trial at
1
site
Chapel Hill, North Carolina 27514
Principal Investigator: Kirsten A Nyrop, PhD
Phone: 919-966-0695
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