Exercise in Metastatic Breast Cancer: EMBody

NCT05468034 | Recruiting DMC

• 1 other identifier: CTO-IUSCCC-0781
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer; Indolent Metastatic Breast Cancer

Keywords

breast cancer; indolent metastatic breast cancer; exercise

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness

  Measured by minutes on the treadmill

  baseline, 16 weeks

Secondary Outcomes (12)

• physical performance battery

  baseline, 8, and 16 weeks

• Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29

  baseline, 8, and 16 weeks

• muscle mass

  baseline, and 16 weeks

• muscle density

  baseline, and 16 weeks

• adipose mass

  baseline, and 16 weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Exercise Intervention

Usual Care

NO INTERVENTION

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.

Interventions

Exercise Intervention BEHAVIORAL

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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (6)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

COMPLETED

IU Health West

Avon, Indiana, 46123, United States

WITHDRAWN

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

WITHDRAWN

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Tarah Ballinger, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niraj Shah

CONTACT

(317) 278-3420; shahnir@iu.edu

Tarah Ballinger, MD

CONTACT

tarab@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 21, 2022
• Study Start: April 26, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (6)