RecruitingNot ApplicableNCT05468034

Exercise in Metastatic Breast Cancer: EMBody

Sponsor

Indiana University

Enrollment

100 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Indolent Metastatic Breast Cancer

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). 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria13

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

Interventions

BEHAVIORALExercise 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.