Exercise program for patients with indolent metastatic breast cancer
Exercise in Metastatic Breast Cancer: EMBody
NA · Indiana University · NCT05468034
This study tests whether a 16-week virtual exercise program can help people with stable metastatic breast cancer feel better and improve their fitness compared to usual care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Drugs / interventions | trastuzumab, pertuzumab, sacituzumab, chemotherapy, immunotherapy |
| Locations | 6 sites (New Haven, Connecticut and 5 other locations) |
| Trial ID | NCT05468034 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a 16-week virtual exercise program on patients with indolent metastatic breast cancer who have not experienced disease progression in the past year. Participants will be randomly assigned to either the exercise intervention or usual care, with the aim of improving cardiorespiratory fitness, physical function, and patient-reported outcomes. The exercise regimen includes both aerobic and resistance training, tailored to the participants' capabilities. The study will enroll up to 100 participants and assess various health metrics throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of metastatic breast cancer who have not shown disease progression in the last 12 months.
Not a fit: Patients currently receiving cytotoxic chemotherapy or those with significant mobility limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance physical fitness and overall well-being for patients with indolent metastatic breast cancer.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in cancer populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut and 5 other locations
- Yale Cancer Center — New Haven, Connecticut, United States (COMPLETED)
- IU Health West — Avon, Indiana, United States (WITHDRAWN)
- IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States (WITHDRAWN)
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States (RECRUITING)
- Sidney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States (WITHDRAWN)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Tarah Ballinger, MD — Indiana University
- Study coordinator: Niraj Shah
- Email: shahnir@iu.edu
- Phone: (317) 278-3420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Indolent Metastatic Breast Cancer, breast cancer, indolent metastatic breast cancer, exercise