RECRUITING

Exercise in Metastatic Breast Cancer: EMBody

Conditions

Breast Cancer Indolent Metastatic Breast Cancer exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exercise in Metastatic Breast Cancer: EMBody

Quick Facts

Study Start:2023-04-26

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05468034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion 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 RPAQ questionnaire administered during screening)
8. Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

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 supercede 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

Contacts and Locations

Study Contact

Jackson Richey

CONTACT

317-274-0922

jaerich@iupui.edu

Tarah Ballinger, MD

CONTACT

tarab@iu.edu

Principal Investigator

Tarah Ballinger, MD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

IU Health West

Avon, Indiana, 46123

United States

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032

United States

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Tarah Ballinger, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-26

Study Completion Date2027-12

Study Record Updates

Study Start Date2023-04-26

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

breast cancer
indolent metastatic breast cancer
exercise

Additional Relevant MeSH Terms

Breast Cancer
Indolent Metastatic Breast Cancer