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Clinical Trial NCT05468034 for Breast Cancer, Indolent Metastatic Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Exercise in Metastatic Breast Cancer: EMBody

Recruiting
Clinical Trial NCT05468034 is an interventional study for Breast Cancer, Indolent Metastatic Breast Cancer that is recruiting. It started on 26 April 2023 with plans to enroll 100 participants. Led by Indiana University, it is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 1 May 2025.
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.
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.
Official Title

Exercise in Metastatic Breast Cancer: EMBody

Conditions
Breast CancerIndolent Metastatic Breast Cancer
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CTO-IUSCCC-0781
NCT ID Number
NCT05468034
Start Date (Actual)
2023-04-26
Last Update Posted
2025-05-01
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
breast cancer
indolent metastatic breast cancer
exercise
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExercise 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 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
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.
No InterventionUsual 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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in cardiorespiratory fitness
Measured by minutes on the treadmill
baseline, 16 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
physical performance battery
total score on short physical performance battery
baseline, 8, and 16 weeks
Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29
Likert-scaled questionnaire, with response scores ranging from 1 to 5. Scores alternate from 1 or 5 being the lowest value.
baseline, 8, and 16 weeks
muscle mass
measured by mg/kg2 on HU on PET/CT scans
baseline, and 16 weeks
muscle density
measured by mg/kg2 on HU on CT scans
baseline, and 16 weeks
adipose mass
measured by mg/kg2 on HU on CT scans
baseline, and 16 weeks
Change in physical activity minutes
measured by accelerometer data
baseline to post 16-week intervention
Change in steps per day
measured by accelerometer data
baseline to post 16-week intervention
Mean fatigue score as measured by the basic fatigue inventory (BFI)
Likert-scaled questionnaire, with response scores ranging from 0 to 10, with 10 being the worse response.
baseline, and16-weeks
Change intention and habits, as measured by the Behavioral Theory Scales
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.
baseline, and 16-weeks
Uptake of the study
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
date open to accrual until closed to accrual, up to 2 years
Adherence with the intervention defined
the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
baseline to post 16-week intervention
change in patient-reported functional limitations, as measured by a functional limitations scale
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.
baseline, and16-weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  1. Age ≥ 18 years

  2. Diagnosis of metastatic breast cancer

  3. No progression of disease in the 12 months prior to screening per the treating investigator

    1. If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
    2. Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible

  4. ECOG performance status of 0-2

  5. Ability to walk on a treadmill without assistive device.

  6. Informed consent and authorization of the release of health information must be obtained according to institutional guidelines

  7. 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)

  8. Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

  1. Receiving cytotoxic chemotherapy at any point in the prior 12 months.

    1. Participants receiving endocrine therapy are eligible.
    2. 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.)

  2. 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
    • History of fragility fracture

  3. Active, untreated brain metastases

Indiana University logoIndiana University288 active trials to explore
Study Responsible Party
Tarah J Ballinger, MD, Principal Investigator, Assistant Professor of Clinical Medicine, Indiana University
Study Central Contact
Contact: Malori Pojar, (317) 274-0899, [email protected]
Contact: Tarah Ballinger, MD, [email protected]
6 Study Locations in 1 Countries

Connecticut

Yale Cancer Center, New Haven, Connecticut, 06510, United States
Brenda Cartmel, PhD, Contact, 203-737-5091, [email protected]
Tara Sanft, MD, Principal Investigator
Recruiting

Indiana

IU Health West, Avon, Indiana, 46123, United States
Malori Pojar, Contact, (317) 274-0899, [email protected]
Tarah Ballinger, MD, Principal Investigator
Recruiting
IU Health Joe and Shelly Schwarz Cancer Center, Carmel, Indiana, 46032, United States
Malori Pojar, Contact, (317) 274-0899, [email protected]
Tarah Ballinger, MD, Principal Investigator
Recruiting
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States
Malori Pojar, Contact, (317) 274-0899, [email protected]
Tarah Ballinger, MD, Principal Investigator
Recruiting
Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, 46202, United States
Malori Pojar, Contact, (317) 274-0899, [email protected]
Tarah Ballinger, MD, Principal Investigator
Recruiting

Massachusetts

Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Anna Tanasijevic, Contact, 617.632.5584, [email protected]
Jennifer Ligibel, MD, Principal Investigator
Recruiting