This clinical trial evaluates the effects of whether an exercise program might impact blood and breast tissue markers (detection of the presence of a disease) to lower the risk of developing breast cancer in women with dense breasts. Breast cancer is a common disease. Studies have shown that women with high breast density seen on a mammogram are at higher risk of developing breast cancer. When tissue looks dense on a mammogram, it means that a higher proportion of the tissue is made up of milk glands and ducts rather than fat. There are no proven breast cancer prevention strategies for women with higher levels of dense breast tissue on mammogram. Information gathered from this study may help researchers determine whether participating in an exercise program can be used as a preventative measure for breast cancer in women with dense breast tissue.
Additional locations may be listed on ClinicalTrials.gov for NCT06322888.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Jennifer Ann Ligibel
Phone: 617-632-3800
Brigham and Women's HospitalStatus: Approved
Contact: Tari A. King
PRIMARY OBJECTIVE:
I. To evaluate the impact of a 12-week aerobic and resistance training exercise intervention (versus [vs.] wait-list control) on circulating irisin in women at increased risk of breast cancer by virtue of having at least 50% density (heterogeneously dense or extremely dense) breast tissue on mammogram.
SECONDARY OBJECTIVES:
I. To assess the impact of a 12-week aerobic and resistance training exercise intervention (vs. wait list control) on the following in women at increased risk of breast cancer by virtue of having at least 50% density (heterogeneously dense or extremely dense) breast tissue on mammogram:
Ia. Physical activity behaviors;
Ib. Strength;
Ic. Cardiorespiratory fitness;
Id. Anthropometric measures.
EXPLORATORY OBJECTIVES:
I. To explore the impact of a 12-week exercise intervention (vs wait list control) on:
Ia. Expression of immune markers (such as CD4, CD8, CD56, CD163, FOXP3, GZMB, PD-1, CD20, MHC1, CD45, CD68, PDL-1, CD11-C, CK18, CK5) and proliferative (such as Ki67, PCNA, MCM2) in benign breast tissue;
Ib. Circulating inflammatory and immune biomarkers.
II. To explore the relationship between changes in circulating irisin and changes in immune and proliferative markers in benign breast tissue in women with increased breast density.
III. To explore the acute impact of exercise on circulating irisin through measurement of circulating irisin levels immediately after an exercise session.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients participate in virtually and/or in-person supervised, as well as unsupervised aerobic and resistance exercise training program with provided equipment over 1 hour twice weekly (BIW) for 12 weeks. Patients also undergo breast biopsy during screening and post-intervention and blood sample collection throughout the study.
GROUP B: Patients maintain baseline exercise behavior and/or usual daily activities for 12 weeks. Patients may optionally participate in the same exercise program following the initial 12-week study period. Patients also undergo breast biopsy and blood sample collection during screening and post-intervention.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer Ann Ligibel
