Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06322888 for Breast Cancer, Breast Cancer Female is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One trial matched filter criteria
Card View
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
Clinical Trial NCT06322888 is an interventional study for Breast Cancer, Breast Cancer Female that is recruiting. It started on March 28, 2024 with plans to enroll 46 participants. Led by Dana-Farber Cancer Institute, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on November 21, 2025.
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
Detailed Description
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance.
The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires.
Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity.
Participants will be in this research study for up to 16 weeks.
It is expected that 46 women will take part in this study.
The Breast Cancer Research Foundation is supporting this research study by providing funding.
Official Title
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
Conditions
Breast CancerBreast Cancer FemaleOther Study IDs
- 23-676
NCT ID Number
Start Date (Actual)
2024-03-28
Last Update Posted
2025-11-21
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
46
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Breast Cancer
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 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. | Exercise Training Program 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. |
No InterventionArm 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Tissue Markers in Exercise Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Tissue Markers in Control Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Meso scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Meso Scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. Additionally, Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Exercise Group | Defined as the percent change in weight for Exercise Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Control Group | Defined as the percent change in weight for Control Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Exercise Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Control Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Exercise Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Control Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Minutes of Total Exercise for Exercise Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
Change in Minutes of Total Exercise for Control Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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
- 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)
Dana-Farber Cancer InstituteBreast Cancer Research FoundationStudy Responsible Party
Jennifer A. Ligibel, MD, Principal Investigator, Principal Investigator, Dana-Farber Cancer Institute
Study Central Contact
Contact: Jennifer Ligibel, MD, 617-632-3800, [email protected]
Contact: Anna Tanasijevic, MPH, 617-632-5584, [email protected]
2 Study Locations in 1 Countries
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Active, not recruiting
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Jennifer Ligibel, MD, Contact, 617-632-3800, [email protected]
Jennifer Ligibel, MD, Principal Investigator
Recruiting