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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
ACTIVE_NOT_RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Jennifer Ligibel, MD
jennifer_ligibel@dfci.harvard.edu
617-632-3800
Backup
Anna Tanasijevic, MPH
anna_tanasijevic@dfci.harvard.edu
617-632-5584
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 46
Treatments
Experimental: Arm A: Exercise Intervention
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.
No_intervention: Arm B: Waitlist Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: Breast Cancer Research Foundation
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov