Exercise in Metastatic Breast Cancer: EMBody
Indiana University
Summary
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.
Description
This is a randomized, two arm, single-center study designed to compare the effect of exercise versus usual care control on the clinical parameter of cardiorespiratory fitness, in patients with metastatic breast cancer with indolent disease biology over a 16-week period. This study will be enrolling up to 100 participants. Participants will be randomized 1:1 in blocks of 4 to the exercise intervention or usual care, stratified by frailty yes/no defined by baseline SPPB score ≤ 8 or \> 8. Primary Objective To compare the effect of a 16-week multimodality, virtually delivered exercise interventi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years 2. Diagnosis of metastatic breast cancer 3. No progression of disease in the 12 months prior to screening per the treating investigator 1. If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible 2. Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible 4. ECOG performance status of 0-2 5. Ability to walk on a treadmill without assistive device. 6. Informed consent and authorization of the release of health info…
Interventions
- BehavioralExercise 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.
Locations (6)
- Yale Cancer CenterNew Haven, Connecticut
- IU Health WestAvon, Indiana
- IU Health Joe and Shelly Schwarz Cancer CenterCarmel, Indiana
- Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Indiana
- Sidney and Lois Eskenazi HospitalIndianapolis, Indiana
- Dana-Farber Cancer InstituteBoston, Massachusetts