Aerobic Exercise for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other malignancy, Metastatic disease, Uncontrolled heart failure, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aerobic exercise can benefit women recently diagnosed with early-stage breast cancer who are undergoing chemotherapy. Participants will engage in various exercise routines, such as aerobic training during or after chemotherapy or a home-based walking program. The goal is to determine if exercise enhances recovery and overall health during and after treatment. Women with early-stage breast cancer who are not currently engaged in intense workouts and are scheduled for chemotherapy might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of exercise during cancer treatment.

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 trial staff or your doctor.

What prior data suggests that aerobic exercise is safe for women with early-stage breast cancer?

Research has shown that aerobic exercise is generally safe for people with breast cancer. It can improve heart health and lower the risk of heart disease. For breast cancer survivors, it might even extend life expectancy.

Aerobic exercise is typically manageable. Participants in various studies have reported increased fitness without serious side effects, indicating that aerobic exercise is a safe choice for those undergoing cancer treatment.

Although this study doesn't focus on safety details, aerobic exercise is often recommended due to its numerous health benefits and minimal risks. It is a good option for enhancing well-being during and after chemotherapy for breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these aerobic exercise treatments for breast cancer because they explore how structured physical activity can enhance recovery and improve patient outcomes during and after chemotherapy. Unlike standard care, which typically focuses on medication and surgery, these treatments integrate personalized aerobic training sessions tailored to each patient's fitness level. By varying the intensity from 55% to 100% of the patient's exercise capacity (VO2peak), these sessions aim to boost cardiovascular health, reduce fatigue, and potentially improve chemotherapy effectiveness. Additionally, the home-based general physical activity group encourages lifestyle changes that could lead to long-term health benefits. This approach might offer a non-invasive, empowering complement to traditional cancer treatments.

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

Research has shown that aerobic exercise benefits breast cancer survivors by improving cardiovascular function and reducing heart disease risk. In this trial, participants will join different treatment arms, such as Aerobic Training After Chemotherapy, Continuous Aerobic Training, and Aerobic Training During Chemotherapy. Another study found that various exercises, including aerobic, reduce fatigue and enhance fitness for breast cancer survivors. These benefits can improve well-being and energy levels during and after treatment. Overall, aerobic exercise effectively aids recovery and enhances the quality of life for breast cancer survivors. ^{2 6 7 8 9}

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 with early-stage operable breast cancer scheduled for chemotherapy, not doing more than 150 minutes of moderate to strenuous exercise weekly. They must pass a baseline exercise test without high-risk heart issues and can't be pregnant or planning pregnancy during the study. Those with other active cancers, metastatic disease, certain heart/lung conditions, mental impairments, or treated malignancies within 3 years (except skin cancer) are excluded.

Inclusion Criteria

You don't exercise for at least 150 minutes per week at a moderate or vigorous level.

Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator

Willingness to be randomized to one of the study arms

Exclusion Criteria

You have a health problem that can affect your ability to exercise or could get worse with exercise.

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

You have a mental condition that makes it hard for you to work together with the study team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo chemotherapy treatment, during which aerobic training sessions are conducted

3-6 months

Weekly supervised exercise sessions

Aerobic Training After Chemotherapy

Participants complete aerobic training sessions after the completion of chemotherapy

6-12 weeks

3 sessions per week

Follow-up

Participants are monitored for changes in VO2 peak, quality of life, and other health metrics

24 weeks

Testing at baseline, mid-point, and follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Training
• Educational Information
• Supervised Home Based Training

Trial Overview

The study examines the impact of supervised aerobic exercise training on women undergoing chemotherapy for early-stage breast cancer. Participants will either perform exercises during or after their chemo treatment and report back to staff about their sessions.

How Is the Trial Designed?

Group I: General Physical Activity Group Experimental Treatment 2 Interventions

Patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a 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 record 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.

Group II: Continuous Aerobic Training Experimental Treatment 1 Intervention

The ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Group III: Aerobic Training During Chemotherapy Experimental Treatment 1 Intervention

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Group IV: Aerobic Training After Chemotherapy Experimental Treatment 1 Intervention

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

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]

Aerobic exercise significantly improves cardiorespiratory fitness (CRF) in breast cancer patients undergoing treatments that may cause cardiotoxicity, with a strong effect size (SMD 1.79) based on a review of 16 trials involving 876 participants.

Exercise regimens that include moderate to vigorous intensity, performed up to three times a week for more than 30 minutes, are particularly effective in enhancing CRF during breast cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise Training to Mitigate Cardiotoxicity of Breast Cancer Therapy: A Systematic Review and Meta-Analysis. Tsai, YL., Chuang, YC., Chen, CP., et al.[2023]

Aerobic exercise significantly improves shoulder joint range of motion (ROM) in breast cancer survivors, as shown by a meta-analysis of nine randomized controlled trials involving 421 patients.

However, the study found no significant improvement in upper limb muscle strength, indicating that while aerobic exercise benefits flexibility, it may not enhance strength in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic exercise on upper limb function following breast cancer treatment: a systematic review and meta-analysis. Yang, Y., Gu, D., Qian, Y., et al.[2021]

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]

Aerobic exercise therapy significantly improved quality of life (QoL) in women treated for breast cancer, with a notable mean difference of 9.8 units in the primary outcome measure compared to usual care after 8 weeks.

The benefits of aerobic exercise therapy extended to various aspects of well-being, including social/family and functional well-being, and were not observed in the exercise-placebo group, indicating that the improvements were specifically due to the aerobic exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of exercise therapy in women treated for breast cancer. Daley, AJ., Crank, H., Saxton, JM., et al.[2022]

Aerobic exercise is an effective additive treatment for cancer patients, helping to alleviate physical limitations and improve quality of life during and after oncological treatment.

Research indicates that aerobic exercise is feasible even for patients with advanced cancer, enabling them to recover physical function and return to a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aerobic endurance training for cancer patients]. Crevenna, R., Zielinski, C., Keilani, MY., et al.[2019]

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]

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