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Aerobic Exercise for Reducing Breast Cancer Risk

N/A

Waitlist Available

Led By Neil Iyengar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being a carrier for BRCA1 and/or BRCA2

Women at high-risk of breast cancer as defined by cytologically confirmed atypical hyperplasia or LCIS

Must not have

Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training

Any newly identified breast abnormality requiring surgical excision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether different amounts of exercise can change risk factors for breast cancer. The participant will self-report their exercise to ExOnc staff, who will then follow up to make sure the information is correct.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed for this type of non-drug intervention trial involving exercise training programs; potential risks may include muscle soreness, fatigue from workouts or injury related to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I carry the BRCA1 or BRCA2 gene mutation.

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I am at high risk for breast cancer due to abnormal cell growth.

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My family history puts me at a high risk for breast cancer.

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My 10-year risk of breast cancer is at least 2.31%.

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My 5-year breast cancer risk is 1.67% or higher.

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I am between 21 and 80 years old.

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I am not pregnant nor planning to become pregnant during the study.

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I am a woman under 50, can become pregnant, and have a recent negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot do certain heart and lung fitness tests or exercises.

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I need surgery for a new breast abnormality.

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I have been diagnosed with an invasive cancer or DCIS before.

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My cancer has spread to other parts of my body.

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I am mentally capable of following study procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nonlinear Aerobic Training

2010

N/A

~210

0 / 13Eligibility criteria met