Aerobic Exercise for Reducing Breast Cancer Risk

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Estrogen modulators, Aromatase inhibitors

Disqualifiers: Invasive cancer, DCIS, Metastatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different amounts of aerobic exercise might reduce the risk of developing breast cancer. Participants will engage in various levels of structured exercise, known as Nonlinear Aerobic Training, to assess its impact on factors like body weight and certain genes related to breast cancer risk. Women identified as high-risk for breast cancer, such as those with specific genetic markers or a family history, might be suitable for this study. The trial will compare different weekly exercise routines to determine which is most effective at lowering risk factors. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new preventive strategies for breast cancer.

Will I have to stop taking my current medications?

The trial requires that you have not used any selective estrogen receptor modulators or aromatase inhibitors, like tamoxifen or anastrozole, within 6 months before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial staff.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that aerobic exercise is generally safe for most people, including those with breast cancer. Studies have found it can lower the risk of heart problems in breast cancer patients by about 29.4%. Most people can perform these exercises without serious issues.

For nonlinear aerobic training, which involves varying exercise intensity, other studies also show it is safe. This type of exercise improved health without causing major problems compared to groups that didn't participate. Aerobic exercise can boost fitness levels, even for those who have undergone cancer treatment, though improvements might be smaller than for those without a cancer history.

Overall, research suggests these exercise programs are safe and beneficial for improving fitness and possibly reducing health risks. Participants should still follow advice from exercise experts and monitor their health, especially when exercising at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nonlinear aerobic training trial because it explores how different intensities and durations of exercise might reduce breast cancer risk. Unlike standard physical activity guidelines, which typically recommend a steady amount of moderate exercise, this trial investigates varying weekly exercise commitments—75, 150, or 300 minutes—tailored to each participant's fitness level. By using a personalized approach based on VO2peak from cardiopulmonary exercise testing (CPET), this method could offer more effective and engaging strategies for cancer prevention. Plus, with the inclusion of both supervised and unsupervised sessions, it provides flexibility that could lead to better adherence and more sustainable lifestyle changes.

What evidence suggests that this trial's treatments could be effective for reducing breast cancer risk?

Research shows that aerobic exercise can significantly lower the risk of developing breast cancer. Studies have found that it improves heart health and overall quality of life for breast cancer patients. In this trial, participants will engage in different levels of nonlinear aerobic training, which boosts exercise capacity by increasing VO2max, a measure of how efficiently the body uses oxygen. This training also aids in weight loss and improves body composition, both important for reducing cancer risk factors. Overall, adding aerobic exercise to a daily routine has been linked to reducing the chance of cancer recurrence and increasing survival rates. ^{1 3 6 7 8}

Who Is on the Research Team?

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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

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

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

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

Exclusion Criteria

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

Your oxygen levels drop to 85% or lower when resting without extra oxygen.

Enrollment on an interventional investigational study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aerobic training with varying intensities and durations to assess impact on breast cancer risk factors

2 years

Regular visits for supervised sessions and self-reported unsupervised sessions

Follow-up

Participants are monitored for changes in gene expression patterns and other risk factors after the training period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nonlinear Aerobic Training

Trial Overview

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.

How Is the Trial Designed?

Group I: Nonlinear Aerobic Training (75 minutes/week) closed to accrual Experimental Treatment 4 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 Treatment 4 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 Treatment 4 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 Activity Active Control 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 20 breast cancer patients undergoing neoadjuvant chemotherapy, those who participated in moderate-to-high intensity aerobic training showed a significant improvement in cardiopulmonary function, with a 13.3% increase in VO2peak compared to a decrease in the control group.

The aerobic training was found to be safe, with only one adverse event reported during the training sessions, and no significant differences in treatment-related side effects between the groups, indicating that it can be a beneficial adjunct therapy during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Hornsby, WE., Douglas, PS., West, MJ., et al.[2022]

Increasing the volume of aerobic exercise to 300 minutes per week significantly reduced the number of women classified as 'nonresponders' in a study of premenopausal women at elevated risk for breast cancer, with only 5.6% being nonresponders compared to 23.5% in the low-dose group.

Both exercise groups (150 and 300 minutes per week) showed a high percentage of women (87.2% and 94.9%, respectively) experiencing a reduction in predicted cancer mortality risk, indicating that even 150 minutes of exercise per week is effective in lowering this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality. Lin, D., Potiaumpai, M., Schmitz, K., et al.[2023]

A 3-week moderate intensity aerobic training program significantly improved aerobic capacity (VO2max) in 18 female breast cancer survivors, with increases of 11.86% in one group and 17.72% in another group.

The study demonstrated that both a predefined workload based on VO2max and a subjective exertion level led to similar improvements in aerobic capacity, indicating flexibility in training approaches for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. Brdareski, Z., Djurović, A., Susnjar, S., et al.[2022]

The CARE Trial, involving 301 breast cancer patients undergoing chemotherapy, found that a combined exercise program of aerobic and resistance training led to better long-term patient-reported outcomes, such as improved sleep quality and overall quality of life, compared to standard aerobic exercise alone.

Participants who engaged in the combined exercise regimen also showed superior health-related fitness, particularly in upper body muscular endurance, highlighting the benefits of incorporating resistance training during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise dose and type during breast cancer chemotherapy on longer-term patient-reported outcomes and health-related fitness: A randomized controlled trial. An, KY., Morielli, AR., Kang, DW., et al.[2020]

Citations

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Aerobic Exercise for Reducing Breast Cancer Risk

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