RightFit
RecruitingNot applicable

Exercise in Metastatic Breast Cancer: EMBody

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire 7."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 16 weeks of supervised online exercise, with aerobic and strength workouts that get harder over time. It is for adults with breast cancer that has spread, has not worsened in the past year, and has not been treated with cell-killing chemotherapy during that year. Researchers want to see whether exercise improves fitness, daily activities, muscle mass, and how people feel.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older and have breast cancer that has spread to other parts of the body.
  • Your cancer has not worsened in the past 12 months. Treatment changes for other reasons are allowed. You may qualify even if you are not on treatment or have no signs of cancer.
  • You can care for yourself and are out of bed or a chair for more than half of your waking hours (ECOG score 0–2).
  • You can walk on a treadmill without a walking aid.
  • You agree to join the study and allow your health information to be shared.
  • A screening survey shows you do less than 150 minutes of moderate to hard exercise each week.
  • You have a mobile device compatible with iOS 15 or Android 7.

Who can't join

  • You received cell-killing chemotherapy in the past 12 months. Hormone therapy, targeted therapy, and antibody therapy are allowed.
  • You have active cancer that has spread to the brain and has not been treated.
  • You have a health condition that prevents supervised exercise. A doctor's letter supporting your participation may allow you to join despite this rule.
  • Examples include serious heart failure, uncontrolled chest pain from heart disease, or a heart attack in the past 12 months.
  • Examples include bone or joint surgery in the past 3 months, planned bone or joint surgery during the study, or a past broken bone caused by weak bones.
  • Examples include uncontrolled long-term lung problems, such as asthma symptoms more than 2 days a week, or breathing trouble that requires oxygen.
  • Examples include poor blood flow in the arms or legs that causes symptoms.
  • Other conditions, including mental health conditions, may exclude you if the study doctor thinks they would prevent you from following the study plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 IPAQ questionnaire administered during screening) 8. Participants should have a cellular device compatible with iOS 15 or Android operating system 7. Exclusion Criteria: 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 supersede 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

Study sites (6)

CT

IN

MA