NCT05468034

Exercise in Metastatic Breast Cancer: EMBody

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 intervention on cardiorespiratory fitness measured by a modified Bruce ramp protocol treadmill test to usual care, in patients with indolent metastatic breast cancer. Secondary Objectives 1. To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP) 2. To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire 3. To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on CT scans obtained as standard of care using SliceOmatic software 4. To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear 5. To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29) 6. To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire 7. To describe patient uptake and adherence with the intervention, measured by proportion of approached patients who consent to the study, and proportion of assigned training sessions attended by patients randomized to the exercise arm.

Conditions

• Breast Cancer
• Indolent Metastatic Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise 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.

Timeline

• Start date: 2023-04-26
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-07-21
• Last updated: 2026-02-05

Locations

6 sites across 1 country: United States