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Behavioral Intervention

Arm A: Exercise Intervention for Breast Cancer

N/A
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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

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

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
1,079 Previous Clinical Trials
340,940 Total Patients Enrolled
141 Trials studying Breast Cancer
22,571 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,757 Total Patients Enrolled
41 Trials studying Breast Cancer
130,467 Patients Enrolled for Breast Cancer
Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
9 Previous Clinical Trials
3,920 Total Patients Enrolled
7 Trials studying Breast Cancer
683 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the principal goals that this medical study aims to achieve?

"The primary aim of this investigation, to be assessed at baseline and week 12 over a period of up to 16 weeks, is the alteration in Irisin levels within the Exercise Group. Additional objectives consist of evaluating the 10-Repetition Max Test results among participants engaging in exercise, which delineates the maximum weight lifted for ten repetitions. The analysis will involve determining changes and relative percent alterations then comparing them between interventions through Wilcoxon rank-sum testing. Furthermore, assessments include variations in Biomarkers within the Exercise Group using Meso Scale technology for detecting inflammatory agents at Dana-Farber Cancer Institute's Translational Research Laboratory. Additionally,"

Answered by AI

Which individuals are eligible for participation in this research study?

"To qualify for enrollment, patients must have a diagnosis of breast carcinoma and fall between the ages of 18 and 59. The study is currently seeking to admit a total of 46 individuals."

Answered by AI

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, recruitment for this research endeavor is currently inactive. The trial was initially listed on March 1st, 2024, with the most recent update occurring on March 19th, 2024. Despite the lack of active recruitment for this particular study, it's worth noting that there are a substantial 2703 alternative trials actively seeking participants at present."

Answered by AI

Are individuals older than 18 years eligible to participate in this study?

"Individuals aged over 18 years and under 59 years are eligible for recruitment into this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
Jennifer A. Ligibel, MD 2024. "Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06322888.
~31 spots leftby Sep 2025
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