Exercise Therapy for Breast Cancer

Recruiting at 1 trial location

Overseen By Jessica Scott, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Unstable angina, Uncontrolled heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different aerobic exercise programs to assess their impact on heart and lung health in women who have completed chemotherapy for early-stage breast cancer. Researchers will evaluate participants' oxygen use and cardiovascular health with various exercise routines. Women who underwent surgery for early-stage breast cancer and completed treatment at least a year ago may qualify if they find exercise challenging. As an unphased trial, this study provides a unique opportunity to contribute to research that may improve recovery and quality of life for women post-chemotherapy.

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 prior data suggests that aerobic training is safe for breast cancer patients?

Research shows that aerobic exercise is generally safe for individuals who have had breast cancer. It is well tolerated, even many years post-treatment. Studies have shown that aerobic exercise can enhance heart and lung function in these individuals.

One study found that women who engaged in aerobic exercise after chemotherapy experienced improved heart and lung fitness. Importantly, these studies reported no major safety concerns.

Overall, exercise has demonstrated positive effects on heart health in people with cancer. While individual responses can vary, aerobic exercise remains a safe and beneficial activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exercise therapy for breast cancer patients because it offers a non-invasive way to potentially improve recovery and overall well-being after chemotherapy. Unlike traditional treatments like surgery, chemotherapy, and radiation, which focus on directly targeting cancer cells, these exercise regimens aim to enhance patients' physical fitness and quality of life through aerobic training. The trial evaluates different durations and intensities of exercise, such as 300 minutes per week for 16 or 32 weeks and 150 minutes per week for similar periods, to see how these variations impact recovery. This approach could offer a complementary benefit, reducing fatigue and improving mental health, making it a promising adjunct to conventional cancer care.

What evidence suggests that aerobic training might be an effective treatment for breast cancer?

Research has shown that aerobic exercise can greatly improve health for breast cancer survivors. One study found that it reduced the risk of heart problems by almost 30% in these patients. Additionally, regular activity is linked to a lower chance of cancer returning and fewer deaths. Exercise enhances heart and lung fitness and boosts overall health in breast cancer survivors. This trial will evaluate different aerobic exercise regimens, with some participants engaging in 300 minutes per week for 32 weeks, while others will follow varying durations and intensities. These findings suggest that aerobic exercise can powerfully support recovery and long-term health after breast cancer treatment. ^{1 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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Training

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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 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 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 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 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]

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