Aerobic Exercise for Breast Cancer

Recruiting at 7 trial locations

Overseen By Anthony Yu, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other cancer, Metastatic malignancy, Mental impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways to use aerobic exercise to assist women with newly diagnosed primary breast cancer who are starting chemotherapy. Researchers compare two exercise plans: one maintains a consistent weekly walking routine (Standard Aerobic Training), while the other adjusts based on participants' responses (Adaptive Aerobic Training). They aim to assess how these routines impact cancer-related fatigue (CRF). Women diagnosed with primary breast cancer who engage in less than 90 minutes of moderate or intense exercise weekly may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the effectiveness of the exercise plans in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research shows that aerobic exercise is generally safe for breast cancer patients. Studies have found that both adaptive and regular aerobic exercise can enhance their quality of life and physical abilities.

Research indicates that adaptive aerobic exercise can safely boost fitness in breast cancer survivors, even those over 65, without causing serious side effects.

Previous research confirms that regular aerobic exercise is also safe for breast cancer patients, including those undergoing chemotherapy. It has been tested for safety and is a practical option for improving health.

Both types of aerobic exercise are generally considered safe and beneficial for breast cancer patients. Studies have not reported any significant serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial because it explores how different aerobic exercise programs can benefit people with newly diagnosed breast cancer who are starting chemotherapy. Unlike current treatments that focus primarily on medication, this trial looks at adaptive aerobic training, which tailors the intensity and duration to each person’s capabilities, potentially offering a more personalized approach. By comparing it with a standard fixed aerobic training regimen, researchers hope to discover if customizing exercise can better support patients during treatment, improve their physical health, and enhance their quality of life.

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

Research shows that exercise, such as aerobic training, can greatly enhance quality of life and reduce fatigue for people with breast cancer. Studies indicate that aerobic exercise lessens cancer-related fatigue and boosts physical ability. In this trial, participants will join one of two treatment arms: Adaptive Aerobic Training, which adjusts exercises based on individual responses, may further improve heart and lung fitness during breast cancer treatment. Meanwhile, Standard Aerobic Training effectively reduces fatigue and enhances quality of life. Both training types can be beneficial, but adaptive training may offer personalized advantages based on individual needs. ^{1 2 5 6 7}

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 over 18 with primary breast cancer, scheduled to receive chemotherapy, and currently exercising less than 90 minutes per week. They must be able to perform a baseline exercise test and agree to follow study procedures. It's not for those with other invasive cancers, severe heart or lung conditions, mental impairments affecting cooperation, or any illness that could interfere with the study.

Inclusion Criteria

I am female.

You exercise moderately or vigorously for less than 90 minutes per week, based on what you tell us.

Willingness to comply with all study-related procedures

Exclusion Criteria

I don't have recent severe heart or lung issues that would stop me from safely doing exercise tests.

You are getting treated for another type of invasive cancer.

I am able to understand and follow study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy for primary breast cancer

32 weeks

Aerobic Training

Participants undergo either standard or adaptive aerobic training to assess effects on cardiorespiratory fitness

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Aerobic Training/AT Dosing
• Standard (fixed) Aerobic Training/AT dosing

Trial Overview

The study compares two types of Aerobic Training (AT) in breast cancer patients undergoing chemotherapy: Standard AT involves a fixed amount of walking each week; Adaptive AT adjusts exercise levels based on participants' responses. The effect on participants' cardiorespiratory fitness (CRF) will be evaluated.

How Is the Trial Designed?

Group I: Adaptive Aerobic Training/AT Dosing Experimental Treatment 1 Intervention

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Group II: Standard (fixed) Aerobic Training/AT dosing Active Control 1 Intervention

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

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

A study involving 58 breast cancer survivors showed that starting a combined aerobic and resistance training program immediately after completing therapy significantly improved overall quality of life (QoL) by 20.8 points compared to a decrease in those who delayed exercise.

The immediate exercise group also experienced similar positive effects on fatigue and physical fitness, demonstrating that early exercise intervention can lead to rapid health improvements in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a combined aerobic and resistance exercise program in breast cancer survivors: a randomized controlled trial. Milne, HM., Wallman, KE., Gordon, S., et al.[2022]

Aerobic exercise training (AET) combined with neoadjuvant chemotherapy (doxorubicin-cyclophosphamide) significantly improved exercise capacity and vascular function in 20 women with early breast cancer, suggesting a beneficial interaction between AET and chemotherapy.

The AET group showed a notable 38% reduction in tumor blood flow, along with changes in circulating factors related to angiogenesis, indicating that AET may influence tumor biology during chemotherapy, although no differences were found in tumor tissue markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. Jones, LW., Fels, DR., West, M., et al.[2021]

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]

Aerobic training was found to be safe for women with metastatic breast cancer, with only 3% of participants lost to follow-up, but the overall attendance rate was lower than the predefined feasibility target, indicating challenges in implementation.

Despite feasibility issues, 42% of patients who completed the aerobic training showed improvements in their peak oxygen consumption (VO2peak) and functional capacity, suggesting potential benefits for select individuals that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. Scott, JM., Iyengar, NM., Nilsen, TS., et al.[2023]

A community-based exercise program over 16 weeks significantly improved aerobic capacity (measured as VO2peak) and physical function in breast cancer survivors, with both groups showing notable enhancements in their exercise performance.

Breast cancer survivors improved their peak cycling power more than control participants, indicating that tailored community exercise interventions can effectively support recovery and fitness in this population, although the improvements may not match those seen in controlled laboratory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer. Lee, JT., Wagoner, CW., Sullivan, SA., et al.[2021]

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]

In a study of 242 breast cancer patients undergoing chemotherapy, those who preferred resistance exercise training (RET) showed significant improvements in quality of life (QoL) when assigned to RET compared to usual care or aerobic exercise training, highlighting the importance of patient preference in exercise interventions.

Demographic and clinical factors, such as marital status, age, chemotherapy regimen, and disease stage, influenced the effectiveness of exercise training, with unmarried, younger patients on nontaxane therapies experiencing better outcomes in terms of strength, lean body mass, and fat loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of the effects of exercise training in breast cancer patients receiving chemotherapy: a randomized controlled trial. Courneya, KS., McKenzie, DC., Mackey, JR., et al.[2008]

A 12-week periodized exercise program aligned with chemotherapy cycles was well tolerated by 28 women with early-stage breast cancer, showing a high attendance rate of 76% and effective completion of prescribed aerobic training.

The exercise program helped maintain peak oxygen uptake (V̇o2peak) during chemotherapy, suggesting that a structured exercise approach may be beneficial for breast cancer patients undergoing treatment, although further randomized trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing Exercise in Early-Stage Breast Cancer During Chemotherapy: A Simple Periodized Approach to Align With the Cyclic Phases of Chemotherapy. Bigaran, A., Howden, EJ., Foulkes, S., et al.[2023]

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]

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