Physical Activity to Maintain Quality of Life and Physical Function in Women With Metastatic Breast Cancer: a Pilot Study

Completed · Not applicable

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT02682836

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

60

Starts

2015-10-01

Expected to finish

2019-12-01

Last updated by the study team

2022-01-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UNC Cancer Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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