Exercise Intervention for Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Tarah Ballinger, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Must not be taking: Cytotoxic chemotherapy

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

No Placebo Group

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.

Trial 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 (Behavioral 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sidney and Lois Eskenazi Hospital Indianapolis, IN

IU Health Joe and Shelly Schwarz Cancer Center Carmel, IN

Indiana University Melvin & Bren Simon Cancer Center Indianapolis, IN

Yale Cancer Center New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1063

Patients Recruited

1,182,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]