Breast Cancer Clinical Trial

Exercise in Metastatic Breast Cancer: EMBody

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.

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Full 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

To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP)
To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire
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
To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear
To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29)
To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire
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.

View Eligibility Criteria

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
Participants must be able to march in place for 30 seconds. Assistance by holding onto a chair is allowed.
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 RPAQ questionnaire administered during screening)

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 supercede 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.
Active, untreated brain metastases

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05468034

Recruitment Status:

Not yet recruiting

Sponsor:

Indiana University

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There are 3 Locations for this study

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IU Health West
Avon Indiana, 46123, United States More Info
Jackson Richey
Contact
317-274-0922
[email protected]
IU Health Joe and Shelly Schwarz Cancer Center
Carmel Indiana, 46032, United States More Info
Jackson Richey
Contact
317-274-0922
[email protected]
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States More Info
Jackson Richey
Contact
317-274-0922
[email protected]
Tarah Ballinger, MD
Principal Investigator
Sidney and Lois Eskenazi Hospital
Indianapolis Indiana, 46202, United States More Info
Jackson Richey
Contact
317-274-0922
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05468034

Recruitment Status:

Not yet recruiting

Sponsor:


Indiana University

How clear is this clinincal trial information?

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