Aerobic Exercise for Reducing Breast Cancer Risk

Recruiting in Palo Alto (17 mi)

Overseen byNeil Iyengar, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

Eligibility Criteria

This trial is for women aged 21-80 at high risk of developing breast cancer, not pregnant or planning pregnancy, and doing less than 120 minutes of exercise per week. They must have a negative pregnancy test if under 50, no history of invasive cancer or current diagnosis, and be able to complete an exercise test without high-risk heart signs.

Inclusion Criteria

A doctor has said that your breast exam looks normal at MSK.

My last mammogram or breast MRI was negative and done within the last year.

You do less than 2 hours of moderate or intense exercise each week.

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Exclusion Criteria

I haven't used estrogen blockers or aromatase inhibitors in the last 6 months.

Enrollment on an interventional investigational study

Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for core biopsy or the trial

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Treatment Details

Interventions

Nonlinear Aerobic Training (Behavioral Intervention)

Trial OverviewThe study tests how different levels of progressive aerobic training affect factors linked to breast cancer risk such as fitness level, weight, body composition, gene expression in breast tissue, and inflammation markers. Participants will report their workout details to the research team.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Nonlinear Aerobic Training (75 minutes/week) closed to accrualExperimental Treatment4 Interventions

The ultimate goal is for participants to complete 75 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the (CPETs performed at baseline, midpoint, and Study Follow-Up. The 75 min/wk will be achieved via 3 individual supervised aerobic training sessions at approximately 25 minutes/session.All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study. This arm is closed to accrual.

Group II: Nonlinear Aerobic Training (300 minutes/week)Experimental Treatment4 Interventions

The ultimate goal is for participants to complete 300 minutes/week of aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from CPETs performed at baseline, midpoint, and Study Follow-Up. The 300 minutes/week will be achieved by completing 5 aerobic training sessions/week for approximately 60 minutes/session. A minimum of 3 sessions/week are required to be supervised while the remaining 2 sessions can be supervised or unsupervised home-based. Participants on all Arms will receive a heart rate monitor prior to beginning unsupervised home-based aerobic training sessions. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.

Group III: Nonlinear Aerobic Training (150 minutes/week)Experimental Treatment4 Interventions

The ultimate goal is for participants to complete 150 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the CTPETs test performed at baseline, midpoint, and Study Follow-Up. The 150 minutes/week will be achieved by completing 3 aerobic training sessions/week for approximately 50 minutes/session. All other on- site participants in Arms A and B will be provided with a heart rate monitor to thank them for completing the study.

Group IV: General Physical ActivityActive Control1 Intervention

Usual care patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to records type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress and answer questions.