Exercise in Metastatic Breast Cancer: EMBody

T
Tarah Ballinger, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase 2
100 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
The purpose of this study is to study exercise in a novel population with indolent MBC (nogression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensitybic and resistance training exercise for 16 weeks in this population will significantlyve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass),blished predictors of survival, and 2) patient- reported outcomes.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
This is a randomized, two arm, single-center study designed to compare the effect of exercise versus usual care control on the clinical parameter of cardiorespiratory fitness, in patients with metastatic breast cancer with indolent disease biology over a 16-week period. This study will be enrolling up to 100 participants. Participants will be randomized 1:1 in blocks of 4he exercise intervention or usual care, stratified by frailty yes/no defined by baselinePPB score ≤ 8 or > 8.
Primary Objective To compare the effect of a 16-week multimodality, virtually deliveredvention on cardiorespiratory fitness measured by a modified Bruce ramp protocoldmill test to usual care, in patients with indolent metastatic breast cancer.
Secondary Objectives
  1. To compare the effect of exercise versus usual care on objective physical functionured by the short physical performance battery (SBBP)
  2. To compare the effect of exercise versus usual care on subjective physical functioningured by PROMIS-29 questionnaire
  3. To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on CT scans obtained asdard of care using SliceOmatic software
  4. To compare the effect of exercise versus usual care on objective physical activityured by accelerometer wear
  5. To compare the effect of exercise versus usual care on patient reported outcomes,uding fatigue (BFI) and health related quality of life (PROMIS-29)
  6. To determine the fidelity of the exercise intervention, measured by changes in measuresucts of habit and intention administered by questionnaire
  7. To describe patient uptake and adherence with the intervention, measured by proportionhed patients who consent to the study, and proportion of assigned trainingded by patients randomized to the exercise arm.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer, Indolent Metastatic Breast Cancer
  • Age: 18 Years
  • Gender: All

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 treatingvestigator
    1. If participant has changed treatments in the prior 12 months for reasons otherhan progressive disease, they remain eligible
    2. Participants on no treatment or "no evidence of disease" but still with adiagnosis of metastatic breast cancer are eligible
  4. ECOG performance status of 0-2
  5. Participants must be able to march in place for 30 seconds. Assistance by holding ontohair is allowed.
  6. Informed consent and authorization of the release of health information must bebtained according to institutional guidelines
  7. Currently not meeting physical activity guidelines (defined as less than 150 minutesderate to vigorous exercise per week measured by the RPAQ questionnairedministered during screening)
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,uzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib,.)
  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 surgeryduring 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 andy with the protocol in the opinion of the investigator, includingychological illness.
  3. Active, untreated brain metastases

Updated on 01 Aug 2024. Study ID: CTO-IUSCCC-0781, 15374
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center