Aerobic Exercise for Cardiovascular Protection in Breast Cancer Patients

(EXACT2 Trial)

Not currently recruiting at 1 trial location

Overseen By Melanie R Keats, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must be taking: AC-based chemotherapy

Disqualifiers: Cognitive limitations, contraindicate aerobic exercise

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether aerobic exercise can protect the heart in breast cancer patients undergoing chemotherapy known to harm heart health. While chemotherapy is crucial for treating cancer, it can sometimes damage the heart, leading to serious issues like heart failure. The study includes two groups: one will follow their regular cancer treatment, and the other will add a 12-week home-based aerobic exercise program to assess its impact on heart health. Suitable participants have been diagnosed with early-stage breast cancer, are about to start a specific type of chemotherapy, and can perform regular aerobic exercise at home. As an unphased trial, this study offers a unique opportunity to contribute to research that may improve heart health 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 coordinators or your doctor.

What prior data suggests that aerobic exercise is safe for breast cancer patients receiving chemotherapy?

Research shows that exercise benefits breast cancer patients. Studies suggest it may reduce cancer treatment side effects and improve quality of life. Exercise might also lower the risk of cancer recurrence and increase survival rates.

Exercise has been linked to better chemotherapy responses, encouraging for those undergoing treatment. While the focus often lies on reducing fatigue and pain, exercise is generally well-tolerated. No serious safety concerns have been reported with aerobic exercise for cancer patients.

Exercise is considered safe for most people, including those with breast cancer. As a non-invasive option, it doesn't involve surgery or inserting anything into the body, making it low-risk and potentially protective for the heart during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic exercise as a treatment for cardiovascular protection in breast cancer patients because it offers a non-invasive, drug-free option that complements standard cancer therapies. Unlike conventional treatments that primarily focus on chemotherapy, radiation, or hormone therapy, aerobic exercise promotes heart health and overall well-being through physical activity. This approach not only aims to improve cardiovascular function but also potentially reduces treatment-related side effects, making it a holistic addition to cancer care.

What evidence suggests that aerobic exercise is effective for heart protection in breast cancer patients?

This trial will compare the effects of aerobic exercise with standard care in breast cancer patients. Studies have shown that aerobic exercise can improve heart health in individuals treated with certain chemotherapy drugs. Research indicates that aerobic exercise can lower the risk of heart problems for those who have undergone breast cancer treatment. Specifically, it enhances the heart and lungs' ability to work together to supply oxygen during physical activity. While aerobic exercise is known to improve fitness, its ability to completely prevent chemotherapy-related heart issues remains under investigation. Overall, aerobic exercise is generally well tolerated and could be a promising way to protect the heart without interfering with cancer treatment. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The EXACT2 trial is for adults over 18 with stages I-III breast cancer who are about to start chemotherapy that can harm the heart. Participants must be cleared by a cardiologist and able to do a 12-week home-based aerobic exercise program. It's not for those with cognitive issues or conditions that make exercise unsafe.

Inclusion Criteria

have medical clearance from a cardiologist (e.g. based on stress test results) to participate in the study.

You must be set to get a specific type of chemotherapy called AC-based chemotherapy with a certain minimum dose.

You can do a 12-week exercise program at home that gradually gets more challenging.

Exclusion Criteria

You have major problems with thinking and understanding.

You have a medical condition that would make it unsafe for you to do aerobic exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anthracycline-based chemotherapy and are randomly assigned to either a control group or an exercise group with a 12-week home-based aerobic exercise program

12 weeks

Weekly monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cardiac function and quality of life assessments

6 months

3 visits (in-person)

Open-label extension (optional)

Participants in the control group may opt into the home-based aerobic exercise program after the follow-up period

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise

Trial Overview

This study tests if regular aerobic exercise can protect the hearts of breast cancer patients from damage caused by anthracycline-based chemotherapy, which is known to potentially lead to heart failure.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.

Group II: Control Active Control 1 Intervention

Participants will receive standard of care treatment for their breast cancer.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

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 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]

A meta-analysis of 11 randomized controlled trials involving 666 breast cancer patients found that physical exercise significantly improves cardiovascular health by lowering systolic and diastolic blood pressure, triglyceride levels, and body mass index.

Exercise also enhances cardiovascular fitness by increasing peak oxygen uptake and high-density lipoprotein cholesterol levels, suggesting it could be an effective intervention for cardiovascular care in breast cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical exercise on the cardiovascular system in breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. Wang, S., Yang, T., Qiang, W., et al.[2021]

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

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Our study indicates that AE has a positive effect in reducing cardiovascular risk factors. The individualization principle of AE deserves more attention in the ...

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While exercise has been shown to improve cardiorespiratory fitness in these patients, its effectiveness in preventing CTRCD remains unclear.

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sciencedirect.com

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In a recent meta-analysis, CRF as measured by peak oxygen consumption (VO2peak) was reduced by 10% after systemic anticancer treatment. This was independent of ...

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Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

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sciencedirect.com

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Consistent evidence exercise improves response to chemotherapy and immunotherapy in breast cancer. • Phase 1 data evaluating dose range and biological activity ...

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Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.

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Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy.