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

75 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Nonlinear Aerobic Training for reducing breast cancer risk?

Research shows that regular physical activity, including aerobic exercise, is linked to a lower risk of breast cancer and improved survival rates for those diagnosed with the disease. Studies indicate that exercise can reduce the risk of cancer recurrence and improve overall survival, especially when started before or after a breast cancer diagnosis. ^{1 2 3 4 5}

Is aerobic exercise generally safe for humans?

Aerobic exercise is generally considered safe for humans and has shown many beneficial effects, including reducing cancer risk and enhancing the efficacy of cancer treatments. It can also help manage symptoms and side effects of cancer and its treatment, such as fatigue and depression. ^{6 7 8 9 10}

How does Nonlinear Aerobic Training differ from other treatments for reducing breast cancer risk?

Nonlinear Aerobic Training is unique because it focuses on varying the intensity and duration of aerobic exercise to potentially reduce breast cancer risk, unlike standard exercise routines that maintain a constant intensity. This approach may help decrease the number of individuals who do not respond to exercise and further reduce cancer mortality risk. ^{2 3 6 11 12}

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.

Research Team

Neil Iyengar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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Effects of a short-term differently dosed aerobic exercise on maximum aerobic capacity in breast cancer survivors: a pilot study. [2022]

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Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Increased Duration of Exercise Decreases Rate of Nonresponse to Exercise but May Not Decrease Risk for Cancer Mortality. [2023]

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Efficacy of Exercise on Breast Cancer Outcomes: A Systematic Review and Meta-analysis of Preclinical Data. [2018]

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Adiposity changes after a 1-year aerobic exercise intervention among postmenopausal women: a randomized controlled trial. [2022]

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Effects of exercise dose and type during breast cancer chemotherapy on longer-term patient-reported outcomes and health-related fitness: A randomized controlled trial. [2020]