Exercise in Metastatic Breast Cancer: EMBody

Overview

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.

Interventions

• 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 tra

Primary outcome measures

• Change in cardiorespiratory fitness [Time frame: baseline, 16 weeks]

Secondary outcome measures (12)

• physical performance battery [Time frame: baseline, 8, and 16 weeks]
• Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29 [Time frame: baseline, 8, and 16 weeks]
• muscle mass [Time frame: baseline, and 16 weeks]
• muscle density [Time frame: baseline, and 16 weeks]
• adipose mass [Time frame: baseline, and 16 weeks]
• Change in physical activity minutes [Time frame: baseline to post 16-week intervention]
• Change in steps per day [Time frame: baseline to post 16-week intervention]
• Mean fatigue score as measured by the Tampa scale for Kinesiophobia (TSK) [Time frame: baseline, and16-weeks]
• Change intention and habits, as measured by the Behavioral Theory Scales [Time frame: baseline, and 16-weeks]
• Uptake of the study [Time frame: date open to accrual until closed to accrual, up to 2 years]
• Adherence with the intervention defined [Time frame: baseline to post 16-week intervention]
• change in patient-reported functional limitations, as measured by a functional limitations scale [Time frame: baseline, and16-weeks]

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
• Ability to walk on a treadmill without assistive device.
• 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 IPAQ questionnaire administered during screening)
• Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

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 supersede 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
• History of fragility fracture
• Active, untreated brain metastases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 6 centers

• Yale Cancer Center — New Haven
• IU Health West — Avon
• IU Health Joe and Shelly Schwarz Cancer Center — Carmel
• Indiana University Melvin & Bren Simon Cancer Center — Indianapolis
• Sidney and Lois Eskenazi Hospital — Indianapolis
• Dana-Farber Cancer Institute — Boston

Publications

• Cancilla MA, Nemati D, Halsey D, Shah N, Sherman M, Kelly N, Zhang P, Kassem N, Kaushal N, Shanahan K, Glenn LK, Ligibel JA, Ballinger TJ. Exercise as part of survivorship care in metastatic breast cancer: protocol for the randomized EMBody trial. BMC Cancer. 2024 Sep 12;24(1):1137. doi: 10.1186/s12885-024-12883-6. PMID 39267010

Identifiers

NCT: NCT05468034 · CTO-IUSCCC-0781

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗