Breast CancerNCT05468034
Exercise in Metastatic Breast Cancer: EMBody
A study testing Exercise Intervention in people with Breast Cancer and Indolent Metastatic Breast Cancer, run by Indiana University at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Indolent Metastatic Breast Cancer
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Apr 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tarah Ballinger, MD contact
6 sites in 1 country
United States6 sites, 2 recruiting
- Withdrawn
IU Health West
Avon, Indiana, 46123
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Anna Tanasijevic, 617.632.5584, Anna_Tanasijevic@DFCI.HARVARD.EDU
Jennifer Ligibel, MD
- Withdrawn
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
- Recruiting
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Niraj Shah, (317) 278-3420, shahnir@iu.edu
Tarah Ballinger, MD
- Withdrawn
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
- Completed
Yale Cancer Center
New Haven, Connecticut, 06510
About this study
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.
Read the 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
- 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.
- Conditions
- Breast Cancer, Indolent Metastatic Breast Cancer
- Being tested
- Exercise Intervention
- Keywords
- breast cancer, indolent metastatic breast cancer, exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Measured by minutes on the treadmill
Measured: baseline, 16 weeks
Secondary outcomes (12)
physical performance battery
total score on short physical performance battery
Measured: 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.
Measured: baseline, 8, and 16 weeks
muscle mass
measured by mg/kg2 on HU on PET/CT scans
Measured: baseline, and 16 weeks
muscle density
measured by mg/kg2 on HU on CT scans
Measured: baseline, and 16 weeks
adipose mass
measured by mg/kg2 on HU on CT scans
Measured: baseline, and 16 weeks
Change in physical activity minutes
measured by accelerometer data
Measured: baseline to post 16-week intervention
Change in steps per day
measured by accelerometer data
Measured: baseline to post 16-week intervention
Mean fatigue score as measured by the Tampa scale for Kinesiophobia (TSK)
17 item Likert scale checklist
Measured: 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.
Measured: baseline, and 16-weeks
Uptake of the study
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
Measured: 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
Measured: 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.
Measured: baseline, and16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start26 Apr 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468034
- Sponsor's protocol ID
- CTO-IUSCCC-0781
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2022
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39267010
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Metastatic Breast Cancer: EMBody
- ClinicalTrials.gov ID
- NCT05468034
- Acronym / sponsor ID
- CTO-IUSCCC-0781
- Conditions
- Breast Cancer, Indolent Metastatic Breast Cancer
- Keywords
- breast cancer, indolent metastatic breast cancer, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionEligible 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Diagnosis of metastatic breast cancer
- No progression of disease in the 12 months prior to screening per the treating investigator
- ECOG performance status of 0-2
- Ability to walk on a treadmill without assistive device.
Key exclusion criteria (13 listed)
- Receiving cytotoxic chemotherapy at any point in the prior 12 months.
- Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supersede this eligibility criteria.
- Active, untreated brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionEligible 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. | Behavioural | Exercise Intervention |
Primary outcome
Change in cardiorespiratory fitness
Time frame: baseline, 16 weeks
Measured by minutes on the treadmill
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 39267010Cancilla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tarah Ballinger, MD contact
Tarah Ballinger, MD principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Breast Cancer and Indolent Metastatic Breast Cancer, run by Indiana University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niraj Shah ((317) 278-3420, shahnir@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness (time frame: baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.