Aerobic Exercise for Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Jessica Scott, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compares two types of walking exercises: one with a fixed routine and one that changes based on how participants respond. The goal is to see which method better improves heart and lung fitness. Participants are people who can benefit from regular walking exercises.

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.

What data supports the effectiveness of the treatment Adaptive Aerobic Training for breast cancer?

Research shows that aerobic exercise, when combined with resistance training during breast cancer chemotherapy, can improve patient-reported outcomes like sleep quality and muscular endurance. Additionally, aerobic training can help reduce the side effects of chemotherapy and improve overall fitness in breast cancer patients. ^{1 2 3 4 5}

Is aerobic exercise safe for breast cancer patients?

Research indicates that aerobic exercise is generally safe for breast cancer patients, including those undergoing chemotherapy. Studies have shown that it can be safely performed and may even help improve quality of life and fitness during and after treatment. ^{1 2 4 5 6}

How is Adaptive Aerobic Training different from other treatments for breast cancer?

Adaptive Aerobic Training is unique because it adjusts the exercise dose based on individual responses, potentially reducing the number of people who do not benefit from exercise and lowering cancer mortality risk. This approach contrasts with standard fixed-dose aerobic training, which does not account for individual variability in exercise response. ^{1 2 7 8 9}

Research Team

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

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

Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. [2023]

2. United States 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. [2020]

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

Moderators of the effects of exercise training in breast cancer patients receiving chemotherapy: a randomized controlled trial. [2008]

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

Modulation of circulating angiogenic factors and tumor biology by aerobic training in breast cancer patients receiving neoadjuvant chemotherapy. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a combined aerobic and resistance exercise program in breast cancer survivors: a randomized controlled trial. [2022]

7. 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]

8. United States 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. [2023]

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

Impact of community-based exercise program participation on aerobic capacity in women with and without breast cancer. [2021]