NCT06322888 Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
| NCT ID | NCT06322888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2024-03-28 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Jennifer Ligibel, MD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06322888 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 59 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06322888 currently recruiting?
Yes, NCT06322888 is actively recruiting participants. Contact the research team at jennifer_ligibel@dfci.harvard.edu for enrollment information.
Where is the NCT06322888 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT06322888 clinical trial?
NCT06322888 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Jennifer Ligibel, MD at Dana-Farber Cancer Institute. The trial plans to enroll 46 participants.
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