Exercise in Metastatic Breast Cancer: EMBody

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 RPAQ questionnaire administered during screening)

• Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

Locations
United States
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Indiana
IU Health West
RECRUITING
Avon
IU Health Joe and Shelly Schwarz Cancer Center
RECRUITING
Carmel
Indiana University Melvin & Bren Simon Cancer Center
RECRUITING
Indianapolis
Sidney and Lois Eskenazi Hospital
RECRUITING
Indianapolis
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Malori Pojar
mpojar@iu.edu
(317) 274-0899
Backup
Tarah Ballinger, MD
tarab@iu.edu
Time Frame
Start Date: 2023-04-26
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Experimental: Exercise 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.
No_intervention: Usual Care
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.
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov