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Behavioral Intervention

Exercise for Breast Cancer Prevention

N/A
Recruiting
Led By Jennifer Ligibel, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how exercise can reduce the risk of breast cancer in women with dense breast tissue by studying changes in breast tissue and blood. Participants will be divided into two groups: the Exercise Training

Who is the study for?
This trial is for women who may have a higher risk of breast cancer due to having dense breast tissue. Participants should be willing to join an exercise program or be placed on a waitlist. Specific eligibility details are not provided, but typically include age range, health status, and no current engagement in similar interventions.
What is being tested?
The REP-D study is testing whether regular exercise can reduce the risk of developing breast cancer in women with dense breasts. It involves comparing changes in breast tissue and blood between those who participate in an exercise training program and those on a waitlist.
What are the potential side effects?
Since this trial involves an exercise training program, potential side effects might include muscle soreness, fatigue, joint pain or injury related to physical activity. However, these are common reactions to new workout routines rather than adverse drug effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Irisin in Control Group
Change in Irisin in Exercise Group
Secondary study objectives
10-Repetition Max Test in Control Group
10-Repetition Max Test in Exercise Group
Change in Biomarkers in Control Group - Mass cytometry
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Exercise InterventionExperimental Treatment1 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.
Group II: Arm B: Waitlist ControlActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Training Program
2019
N/A
~200

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,105 Previous Clinical Trials
359,487 Total Patients Enrolled
10 Trials studying Breast Cancer
1,092 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
71 Previous Clinical Trials
137,777 Total Patients Enrolled
2 Trials studying Breast Cancer
210 Patients Enrolled for Breast Cancer
Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
9 Previous Clinical Trials
3,920 Total Patients Enrolled
1 Trials studying Breast Cancer
2 Patients Enrolled for Breast Cancer
~28 spots leftby Sep 2025
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