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Exercise Intervention for Metastatic Breast Cancer
Phase 2
Recruiting
Led By Tarah Ballinger, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-2
Participants on no treatment or 'no evidence of disease' but still with a diagnosis of metastatic breast cancer are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date open to accrual until closed to accrual, up to 5 years
Awards & highlights
Study Summary
This trial is testing if exercise can help people with a specific type of breast cancer that has not progressed for at least a year and are not currently receiving chemotherapy. The team believes that 16 weeks of exercise will improve the patient's aerobic fitness, functional status, and muscle mass, as well as their quality of life.
Who is the study for?
This trial is for adults over 18 with metastatic breast cancer who haven't seen their disease progress in the last year. They should not be currently meeting exercise guidelines and must be able to march in place for half a minute. People with recent heart attacks, uncontrolled heart failure or asthma, severe comorbidities, upcoming orthopedic surgery, active brain metastases, or those on cytotoxic chemotherapy within the past year can't join.Check my eligibility
What is being tested?
The EMBody trial tests a virtual exercise program combining aerobic and resistance training over 16 weeks for people with stable metastatic breast cancer. The goal is to see if this improves fitness levels, muscle mass (sarcopenia), functional status—all linked to survival—and patient-reported outcomes.See study design
What are the potential side effects?
Since this study involves an exercise intervention rather than medication, side effects may include typical exercise-related issues such as muscle soreness or strain but will vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have metastatic breast cancer but am currently not on treatment or show no signs of the disease.
Select...
My condition has not worsened in the past year.
Select...
I am 18 years old or older.
Select...
My breast cancer has spread to other parts of my body.
Select...
I can march in place for 30 seconds, with support if needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date open to accrual until closed to accrual, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date open to accrual until closed to accrual, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cardiorespiratory fitness
Secondary outcome measures
Adherence with the intervention defined
Change in physical activity minutes
Change in steps per day
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,662 Total Patients Enrolled
15 Trials studying Breast Cancer
3,470 Patients Enrolled for Breast Cancer
Tarah Ballinger, MDPrincipal InvestigatorIndiana University
6 Previous Clinical Trials
213 Total Patients Enrolled
3 Trials studying Breast Cancer
150 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have metastatic breast cancer but am currently not on treatment or show no signs of the disease.I have symptoms of poor blood flow in my limbs.I have chest pain that isn't managed by medication.My condition has not worsened in the past year.I have severe heart failure.I have severe lung problems needing oxygen or have asthma symptoms more than twice a week.I have had a heart attack in the last year.I am 18 years old or older.I have not had orthopedic surgery in the last 3 months and do not plan to during the study.I changed my cancer treatment in the last year for reasons other than worsening.I have brain metastases that haven't been treated.My breast cancer has spread to other parts of my body.I have had chemotherapy in the last year.You do not exercise enough, as measured by a questionnaire, and do less than 150 minutes of moderate to vigorous exercise each week.I can march in place for 30 seconds, with support if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could Exercise Intervention put people's health at risk?
"The safety of the exercise intervention is rated a 2, as there is some evidence for its protection but no data on its efficacy."
Answered by AI
Are there any open spots left in this clinical trial?
"Based on the clinicaltrials.gov registry, this particular medical study is not currently accepting any more patients. This trial first appeared in November 1st 2022 and was last updated October 12th of that same year. However, there are still 2596 other investigations actively recruiting participants at present time."
Answered by AI
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