Exercise Intervention for Metastatic Breast Cancer

Recruiting at 5 trial locations

Overseen By Malori Pojar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Congestive heart failure, Angina, Myocardial infarction, Orthopedic surgery, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants receiving endocrine therapy, targeted therapy, or antibody therapy are eligible, but those on cytotoxic chemotherapy in the past 12 months are not eligible.

What data supports the effectiveness of the treatment Exercise Intervention for Metastatic Breast Cancer?

Research shows that exercise can improve fitness, physical performance, and quality of life in patients with metastatic breast cancer. A study found that aerobic exercise was safe and beneficial, leading to increased physical capacity and better quality of life for a patient with advanced breast cancer and bone metastases. ^{1 2 3 4 5}

Is exercise intervention safe for breast cancer patients?

Research shows that exercise interventions, including aerobic and resistance training, are generally safe for breast cancer patients. Studies have monitored adverse events and found no significant safety concerns, making exercise a recommended therapy for improving fitness in cancer patients. ^{1 6 7 8 9}

How is the exercise intervention treatment different from other treatments for metastatic breast cancer?

The exercise intervention for metastatic breast cancer is unique because it focuses on improving fitness, functional capacity, and quality of life through physical activity, rather than using medication or surgery. This approach is novel as it emphasizes aerobic and resistance training, which has been less explored in this patient group. ^{1 3 5 10 11}

Research Team

Tarah Ballinger, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with metastatic breast cancer who haven't seen their disease progress in the last year. They should not be currently meeting exercise guidelines and must be able to march in place for half a minute. People with recent heart attacks, uncontrolled heart failure or asthma, severe comorbidities, upcoming orthopedic surgery, active brain metastases, or those on cytotoxic chemotherapy within the past year can't join.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I have metastatic breast cancer but am currently not on treatment or show no signs of the disease.

My condition has not worsened in the past year.

Exclusion Criteria

I have symptoms of poor blood flow in my limbs.

I have chest pain that isn't managed by medication.

I have severe heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 16-week multimodality, virtually delivered exercise intervention or usual care

16 weeks

3 virtual sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exercise Intervention

Trial Overview The EMBody trial tests a virtual exercise program combining aerobic and resistance training over 16 weeks for people with stable metastatic breast cancer. The goal is to see if this improves fitness levels, muscle mass (sarcopenia), functional status—all linked to survival—and patient-reported outcomes.

Participant Groups

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

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]

Exercise can significantly improve survival and quality of life for patients with metastatic cancer, although specific guidelines for physical activity in this group are still lacking.

Physical activity is generally safe for cancer patients, including the elderly and those with bone metastases, but exercise programs should be personalized based on each patient's health status and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions in metastatic cancer disease: a literature review and a brief discussion on current and future perspectives. Wilk, M., Kepski, J., Kepska, J., et al.[2021]

A 16-week moderate-intensity exercise program for women with metastatic breast cancer did not show significant improvements in physical functioning or weekly exercise minutes compared to a control group, indicating that exercise may not be as beneficial for this population as it is for those with early-stage breast cancer.

Despite the lack of significant results, the study highlights the need for further research to explore alternative interventions that could help women with metastatic breast cancer manage symptoms and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of a physical activity intervention in women with metastatic breast cancer. Ligibel, JA., Giobbie-Hurder, A., Shockro, L., et al.[2016]

A 48-year-old woman with advanced breast cancer showed significant improvements in her physical fitness, with VO2max increasing by 52.7% after 12 months of a structured aerobic exercise program.

The exercise program, which involved cycling three times a week, not only enhanced her peak work capacity by 35.7% but also led to a notable improvement in her overall quality of life, suggesting that aerobic exercise can be a beneficial palliative treatment for cancer patients with bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise for a patient suffering from metastatic bone disease. Crevenna, R., Schmidinger, M., Keilani, M., et al.[2004]

A survey of 420 metastatic breast cancer patients revealed that while 68% felt skilled enough for aerobic exercise, only 35% felt confident in resistance exercise, indicating a gap in exercise engagement.

Barriers such as lack of access to programs, fatigue, and weakness hinder participation, but personalized advice and positive past experiences can encourage regular exercise, highlighting the need for tailored support and consideration of insurance reimbursement in program implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries. Sweegers, MG., Depenbusch, J., Kampshoff, CS., et al.[2023]

Exercise therapy significantly improves cardiorespiratory fitness (CRF) in patients with adult-onset cancer, with an average increase of 2.80 mL O2 × kg-1 × min-1 compared to no change in control groups, based on a review of 48 randomized controlled trials involving 3,632 patients.

The study found that exercise therapy is safe, with only 44 adverse events reported across 30 trials, and high adherence rates (88%) suggest that patients are likely to stick with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. Scott, JM., Zabor, EC., Schwitzer, E., et al.[2022]

A 12-week aerobic exercise program for breast cancer patients after treatment showed significant improvements in physical performance, with agility and peak jumping power increasing by approximately 5% and 10%, respectively.

The exercise regimen was feasible, with a 78% adherence rate, and may also help prevent bone loss due to the high reaction forces experienced during training, suggesting potential benefits for bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a vigorous aerobic regimen on physical performance in breast cancer patients - a randomized controlled pilot trial. Nikander, R., Sievänen, H., Ojala, K., 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]

A systematic review of 50 studies on resistance training for breast cancer patients found that only 66% adhered to the American College of Sports Medicine guidelines, indicating a gap in compliance with established exercise recommendations.

Despite an average adherence rate of 84%, many studies did not specify the exercises used, and only half of the regimens were designed to achieve muscle hypertrophy, suggesting a need for better-defined exercise protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? Rosenberg, J., Hyde, PN., Yancy, WS., et al.[2023]

The Therapeutic Exercise program for women with metastatic breast cancer was found to be safe and feasible, with improvements in cancer-related fatigue and functional parameters for those who completed the program.

Despite the positive outcomes for participants, only 11 out of 30 patients completed the 12-week program, indicating challenges with compliance primarily due to personal issues and symptoms from the disease or treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Standard Care Program of Therapeutic Exercise in Metastatic Breast Cancer Patients. Pajares, B., Roldán-Jiménez, C., Alba, E., et al.[2023]

The ABLE Trial, involving 49 women with metastatic breast cancer over 6 months, demonstrated that a home-based walking program significantly improved physical fitness, with a 7% increase in walking distance and a 22% increase in quadriceps strength.

Participants showed high adherence (96%) to the exercise program, indicating a strong willingness to engage in physical activity, which may lead to better health outcomes and encourage a more active lifestyle among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. Delrieu, L., Pialoux, V., Pérol, O., et al.[2021]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Exercise interventions in metastatic cancer disease: a literature review and a brief discussion on current and future perspectives. [2021]

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

Randomized trial of a physical activity intervention in women with metastatic breast cancer. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Aerobic exercise for a patient suffering from metastatic bone disease. [2004]

5. Germany pubmed.ncbi.nlm.nih.gov

Perspectives of patients with metastatic breast cancer on physical exercise programs: results from a survey in five European countries. [2023]

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

Efficacy of Exercise Therapy on Cardiorespiratory Fitness in Patients With Cancer: A Systematic Review and Meta-Analysis. [2022]

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

Effect of a vigorous aerobic regimen on physical performance in breast cancer patients - a randomized controlled pilot trial. [2022]

8. 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]

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

Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective? [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of a Standard Care Program of Therapeutic Exercise in Metastatic Breast Cancer Patients. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. [2021]