This randomized pilot clinical trial studies how well aerobic exercise training works in lowering the risk of breast cancer in patients at high-risk for development of breast cancer. Aerobic exercise training may help lower the risk of breast cancer patients with risk factors that are associated with developing breast cancer such as exercise capacity, body weight, body composition, the expression of certain genes, and levels of inflammatory factors in breast tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02494869.
PRIMARY OBJECTIVE:
I. To determine the dose-response of aerobic training on the gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for the development of breast cancer.
SECONDARY OBJECTIVES:
I. To determine the dose-response of aerobic training on proinflammatory profile in epithelial cells and surrounding stroma.
II. To determine the dose-response of aerobic training on changes in circulating angiome/proinflammatory growth factors.
III. To determine the dose-response of aerobic training on exercise capacity.
IV. To determine the dose-response of aerobic training on body composition.
V. Frozen and paraffin embedded tissue will be archived for future exploratory studies.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM A: Patients undergo instructor-led aerobic exercise training sessions for 25 minutes 3 times per week for up to 24 weeks. (Arm closed March 18, 2018)
ARM B: Patients undergo instructor-led aerobic exercise training sessions for 50 minutes 3 times per week for up to 24 weeks.
ARM C: Patients undergo instructor-led aerobic exercise training sessions for 60 minutes 5 times per week for up to 24 weeks. A minimum of 3 sessions per week are required to be instructor-led while the remaining 2 sessions can be instructor-led or home-based.
ARM D: Patients undergo in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of normal daily activity.
After completion of study, patients are followed up for 24 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott