Exercise in Metastatic Breast Cancer: EMBody
Breast Cancer, Indolent Metastatic Breast Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, indolent metastatic breast cancer, exercise
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of metastatic breast cancer
No progression of disease in the 12 months prior to screening per the treating investigator
- If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
- Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
- ECOG performance status of 0-2
- Participants must be able to march in place for 30 seconds. Assistance by holding onto a chair is allowed.
- Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
- Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the RPAQ questionnaire administered during screening)
Exclusion Criteria:
Receiving cytotoxic chemotherapy at any point in the prior 12 months.
- Participants receiving endocrine therapy are eligible.
- Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supercede this eligibility criteria.
- NYHA class III or IV congestive heart failure
- Uncontrolled angina
- Myocardial infarction in the prior 12 months
- Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
- Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
- Symptomatic peripheral vascular disease
- Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness.
- Active, untreated brain metastases
Sites / Locations
- IU Health WestRecruiting
- IU Health Joe and Shelly Schwarz Cancer CenterRecruiting
- Indiana University Melvin & Bren Simon Cancer CenterRecruiting
- Sidney and Lois Eskenazi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Exercise Intervention
Usual Care
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.
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.