Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05468034

Exercise in Metastatic Breast Cancer: EMBody

Led by Indiana University · Updated on 2026-04-27

100

Participants Needed

6

Research Sites

240 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Exercise in Metastatic Breast Cancer: EMBody

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of metastatic breast cancer
  • No disease progression in the 12 months before screening
  • ECOG performance status between 0 and 2
  • Ability to walk on a treadmill without an assistive device
  • Informed consent and authorization for health information release
  • Currently exercising less than 150 minutes per week of moderate to vigorous activity
  • Access to a cellular device compatible with iOS 15 or Android 7 or higher
Not Eligible

You will not qualify if you...

  • Receiving cytotoxic chemotherapy in the past 12 months
  • Conditions preventing supervised exercise participation unless a physician letter supports participation, including:
    • NYHA class III or IV congestive heart failure
    • Uncontrolled angina
    • Myocardial infarction within the past 12 months
    • Orthopedic surgery in the past 3 months or planned during the study
    • Chronic uncontrolled pulmonary conditions like asthma with symptoms more than 2 days per week or oxygen requirement
    • Symptomatic peripheral vascular disease
    • Other comorbidities interfering with study compliance, including psychological illness
    • History of fragility fracture
  • Active, untreated brain metastases

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Yale Cancer Center

New Haven, Connecticut, United States, 06510

Completed

2

IU Health West

Avon, Indiana, United States, 46123

Withdrawn

3

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States, 46032

Withdrawn

4

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

5

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States, 46202

Withdrawn

6

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

N

Niraj Shah

CONTACT

T

Tarah Ballinger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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