Exercise in Metastatic Breast Cancer: EMBody
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
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To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP)
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To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire
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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
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To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear
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To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29)
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To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise Intervention Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer three times weekly for 16 weeks. Training sessions are 60 minutes. Schedules are determined by the participant and their 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 three 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. |
Behavioral: Exercise Intervention
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer three times weekly for 16 weeks. Training sessions are 60 minutes. Schedules are determined by the participant and their 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 three 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.
|
| No Intervention: Usual Care 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. |
Outcome Measures
Primary Outcome Measures
- Change in cardiorespiratory fitness [baseline, 16 weeks]
Measured by minutes on the treadmill
Secondary Outcome Measures
- physical performance battery [baseline, 8, and 16 weeks]
total score on short physical performance battery
- Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29 [baseline, 8, and 16 weeks]
Likert-scaled questionnaire, with response scores ranging from 1 to 5. Scores alternate from 1 or 5 being the lowest value.
- muscle mass [baseline, and 16 weeks]
measured by mg/kg2 on HU on CT scans
- muscle density [baseline, and 16 weeks]
measured by mg/kg2 on HU on CT scans
- adipose mass [baseline, and 16 weeks]
measured by mg/kg2 on HU on CT scans
- Change in physical activity minutes [baseline to post 16-week intervention]
measured by accelerometer data
- Change in steps per day [baseline to post 16-week intervention]
measured by accelerometer data
- Mean fatigue score as measured by the basic fatigue inventory (BFI) [baseline, and16-weeks]
Likert-scaled questionnaire, with response scores ranging from 0 to 10, with 10 being the worse response.
- Change intention and habits, as measured by the Behavioral Theory Scales [baseline, and 16-weeks]
Likert-scaled questionnaire, measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores are summed in the range of 40 to 200, with a higher score indicating stronger motivation that could predict exercise behavior.
- Uptake of the study [date open to accrual until closed to accrual, up to 5 years]
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
- Adherence with the intervention defined [baseline to post 16-week intervention]
the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
- change in patient-reported functional limitations, as measured by a functional limitations scale [baseline, and16-weeks]
mean score of 5 question scale, where participants responses are either scored 0 or 1, with "some difficulty" a 1 and "no difficulty" as a 0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Diagnosis of metastatic breast cancer
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No progression of disease in the 12 months prior to screening per the treating investigator
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If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
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Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
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ECOG performance status of 0-2
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Participants must be able to march in place for 30 seconds. Assistance by holding onto a chair is allowed.
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Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
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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:
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Receiving cytotoxic chemotherapy at any point in the prior 12 months.
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Participants receiving endocrine therapy are eligible.
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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.)
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Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supercede this eligibility criteria.
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NYHA class III or IV congestive heart failure
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Uncontrolled angina
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Myocardial infarction in the prior 12 months
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Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
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Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
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Symptomatic peripheral vascular disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IU Health West | Avon | Indiana | United States | 46123 |
| 2 | IU Health Joe and Shelly Schwarz Cancer Center | Carmel | Indiana | United States | 46032 |
| 3 | Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 4 | Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
Investigators
- Principal Investigator: Tarah Ballinger, MD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTO-IUSCCC-0781