Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

NCT06322888 | Recruiting

• 1 other identifier: 23-676
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. The names of the study groups in this study are:

• Exercise Training Group
• Waitlist Control Group

Conditions

Breast Cancer; Breast Cancer Female

Keywords

Breast Cancer; Breast Cancer Female; Breast Cancer Risk; Dense breast tissue; Dense breasts

Outcome Measures

Primary Outcomes (2)

• Change in Irisin in Exercise Group

  Change in circulating irisin at baseline, after 1st exercise session, and end of study in exercise group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.

  At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks

• Change in Irisin in Control Group

  Change in circulating irisin at baseline and end of study in control group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.

  At baseline and week 12, up to 16 weeks

Secondary Outcomes (14)

• Change in Tissue Markers in Exercise Group

  At baseline and week 12, up to 16 weeks

• Change in Tissue Markers in Control Group

  At baseline and week 12, up to 16 weeks

• Change in Biomarkers in Exercise Group - Meso scale

  At baseline and week 12, up to 16 weeks

• Change in Biomarkers in Exercise Group - Mass cytometry

  At baseline and week 12, up to 16 weeks

• Change in Biomarkers in Control Group - Meso Scale

  At baseline and week 12, up to 16 weeks

Study Arms (2)

Arm A: Exercise Intervention

EXPERIMENTAL

Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session. * End of study visit with assessments, breast biopsy, and blood draw.

Behavioral: Exercise Training Program

Arm B: Waitlist Control

NO INTERVENTION

Participants will be randomized and will complete: * Baseline study visit with assessments, breast biopsy, and blood draw. * End of study visit with assessments, breast biopsy, and blood draw. * Participants will be offered a complimentary 12-week exercise program after completing the study.

Interventions

Exercise Training Program BEHAVIORAL

A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study.

Arm A: Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-59
• Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
• Physically inactive; engaging in \<60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
• Not pregnant or breastfeeding
• English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
• Written informed consent prior to any study-related procedures

You may not qualify if:

• Self-reported inability to walk 2 blocks (at any pace)
• Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
• On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
• Consistent strength training in the past 3 months
• Use of weightloss drugs
• Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
• Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ligibel, MD

CONTACT

617-632-3800; jennifer_ligibel@dfci.harvard.edu

Anna Tanasijevic, MPH

CONTACT

617-632-5584; anna_tanasijevic@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 21, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)