Exercise in Metastatic Breast Cancer: EMBody
Recruiting · NCT05468034 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
Exercise Intervention
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 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.
Exclusion criteria
- 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
- 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
Where it is running
6 locations listed across 3 US states.
- Yale Cancer Center - New Haven, Connecticut, United States
- IU Health West - Avon, Indiana, United States
- IU Health Joe and Shelly Schwarz Cancer Center - Carmel, Indiana, United States
- Indiana University Melvin & Bren Simon Cancer Center - Indianapolis, Indiana, United States
- Sidney and Lois Eskenazi Hospital - Indianapolis, Indiana, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States