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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Breast Cancer; Breast Cancer Female

Treatments: Behavioral: Exercise Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06322888

23-676

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Arm A: Exercise Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Training Program

Arm B: Waitlist Control

No Intervention group

Description:

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.