Exercise Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Jessica Scott, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Unstable angina, Uncontrolled heart failure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.

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 coordinators or your doctor.

What data supports the effectiveness of the treatment Aerobic Training, Aerobic Exercise, Cardiovascular Exercise, Physical Activity Therapy for breast cancer?

Research shows that aerobic exercise can improve upper limb function, heart and lung health, and overall quality of life in breast cancer patients. It also helps reduce the side effects of chemotherapy and supports recovery, making it a beneficial part of breast cancer rehabilitation. ^{1 2 3 4 5}

Is aerobic exercise safe for breast cancer patients?

Research shows that aerobic exercise is generally safe for breast cancer patients, including those with advanced stages of the disease. It can help improve physical function and quality of life without causing harm. ^{1 3 5 6 7}

How is aerobic exercise therapy unique for breast cancer treatment?

Aerobic exercise therapy is unique for breast cancer treatment because it not only helps improve upper limb function and cardiopulmonary health but also enhances overall quality of life by reducing fatigue and psychological distress. Unlike traditional treatments, it focuses on rehabilitation and recovery through physical activity, promoting an active lifestyle and addressing both physical and emotional effects of cancer. ^{1 2 4 5 8}

Research Team

Jessica Scott, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for post-menopausal women aged 21-80 who have completed treatment for early stage (I-III) breast cancer within the last 1-5 years. Participants should be able to perform a baseline exercise test without high-risk heart issues and must have lower than expected fitness levels for their age.

Inclusion Criteria

I am post-menopausal, as defined by age, lack of menstruation, treatment, or hormone levels.

I can complete a fitness test without showing signs of heart risk.

It's been 1-5 years since I completed my cancer treatment involving surgery and either radiation, chemotherapy, or trastuzumab.

Exclusion Criteria

I don't have any major heart, lung, recent cancer, or other health issues that would make exercise testing unsafe for me.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic exercise programs with varying intensities and durations to improve cardiovascular health

32 weeks

Weekly supervised sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aerobic Training (Behavioural Intervention)

Trial Overview The study tests how different amounts and durations of aerobic exercise affect cardiovascular health in participants. It measures oxygen use, heart function, lung capacity, and blood vessel health through various exercise programs.

Participant Groups

Group I: (C) breast cancer after completion of chemo Experimental Treatment 1 Intervention

300 min/wk for 32 weeks.

Group II: (B) breast cancer after completion of chemo Experimental Treatment 1 Intervention

150 min/wk for 32 weeks.

Group III: (A) breast cancer after completion of chemo Experimental Treatment 1 Intervention

300 min/wk for 16 weeks, followed by 16 weeks of usual care.

Group IV: (D) breast cancer after completion of chemo Active Control 1 Intervention

150 min/wk for 16 weeks, followed by 16 weeks of usual care.

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

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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 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 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 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]

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]

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. Austria pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

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

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

5. 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]

6. 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]

7. 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]

8. 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]