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

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. 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.

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.

Is aerobic exercise safe for breast cancer patients?

Research shows that aerobic exercise is generally safe for breast cancer patients, even those undergoing chemotherapy, and can help reduce some treatment side effects. ^{1 2 3 4 5}

How does aerobic exercise treatment differ from other treatments for breast cancer?

Aerobic exercise is unique because it focuses on improving physical function and quality of life by enhancing upper limb function, cardiopulmonary health, and overall well-being, rather than directly targeting cancer cells like traditional treatments such as chemotherapy or radiation. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Aerobic Training, Aerobic Exercise, Cardiovascular Exercise, Physical Activity Therapy, Educational Information, Supervised Home Based Training for breast cancer?

Research shows that aerobic exercise can help breast cancer patients improve their physical function, reduce side effects of chemotherapy, and enhance their quality of life. It has been found to improve upper limb function and cardiopulmonary health, making it a beneficial part of rehabilitation after breast cancer treatment. ^{1 2 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 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

I am fully active or can carry out light work.

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

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]

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 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 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]

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 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 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]

Citations

1. 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]

2. Austria pubmed.ncbi.nlm.nih.gov

[Aerobic endurance training for cancer patients]. [2019]

3. China pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic exercise on upper limb function following breast cancer treatment: a systematic review and meta-analysis. [2021]

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

Randomized trial of exercise therapy in women treated for breast cancer. [2022]

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. 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]

7. England pubmed.ncbi.nlm.nih.gov

Effects of physical exercise on outcomes of cardiac (dys)function in women with breast cancer undergoing anthracycline or trastuzumab treatment: study protocol for a systematic review. [2023]

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

Feasibility of Aerobic Exercise Training to Mitigate Cardiotoxicity of Breast Cancer Therapy: A Systematic Review and Meta-Analysis. [2023]

9. Iran pubmed.ncbi.nlm.nih.gov

The Impact of Aerobic Exercise on Quality of Life in Women with Breast Cancer: A Randomized Controlled Trial. [2020]

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

A meta-analysis of aerobic exercise interventions for women with breast cancer. [2022]