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A Virtual Exercise Intervention for Improving Physical Fitness, Survival, and Quality of Life in Patients with Metastatic Breast Cancer, EMBody Study
Trial Status: active
This clinical trial evaluates the effects of a virtual exercise intervention on physical fitness, survival, and quality of life in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Physical activity and exercise are associated with significantly improved outcomes in early stage breast cancer including disease-specific and overall survival, treatment tolerability, and quality of life. However, little is known about the effects of exercise in patients with metastatic breast cancer. This clinical trial evaluates the effects of a virtual exercise intervention including cardiovascular exercise, resistance training, and balance or stretching exercises on the health outcomes of patients with metastatic breast cancer.
Inclusion Criteria
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Ability to walk on a treadmill without an 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 International Physical Activity Questionnaire [IPAQ] questionnaire administered during screening)
Participants should have a cellular device compatible with iOS 15 or Android operating system 7
Exclusion Criteria
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
* New York Heart Association (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05468034.
I. To compare the effect of a 16-week multimodality, virtually delivered exercise intervention on cardiorespiratory fitness measured by a modified Bruce ramp protocol treadmill test to usual care, in patients with indolent metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP).
II. To compare the effect of exercise versus usual care on subjective physical functioning measured by Patient Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire.
III. To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on computed tomography (CT) scans obtained as standard of care using SliceOmatic software.
IV. To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear.
V. To compare the effect of exercise versus usual care on patient reported outcomes, including Tampa scale for Kinesiophobia (TSK) and health related quality of life (PROMIS-29).
VI. To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire.
VII. To describe patient uptake and adherence with the intervention, measured by proportion of approached patients who consent to the study, and proportion of assigned training sessions attended by patients randomized to the exercise arm.
EXPLORATORY OBJECTIVES:
I. Explore whether exercise versus usual care impacts quantitative circulating tumor cell measurement in patients with indolent metastatic breast cancer.
II. Explore phenotypic predictors of adherence and efficacy of the intervention, including race, age, disease characteristics, social determinants of health, and behavioral constructs.
III. Explore impact of exercise versus usual care on progression- free survival (PFS) and long- term patient reported outcomes.
IV. Explore differences in serologic markers of inflammation (c-reactive protein [CRP], IL-6, TNFalpha), adipokines (leptin, adiponectin), and metabolism (insulin, IGF-1) in the intervention versus usual care groups.
V. Collect blood samples for future circulating tumor cell analysis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in virtual exercise sessions with an exercise trainer over 60 minutes three times a week (TIW) for 16 weeks on study and attend an educational session over 1 hour within 14 days of randomization. Patients may undergo collection of blood samples at baseline and day 112 and may optionally undergo CT at baseline and day 112.
ARM II: Patients receive their usual care on study. Patients may undergo collection of blood samples at baseline and day 112 and may optionally undergo CT at baseline and day 112.
After completion of study intervention, patients are followed up every 6 months until disease progression or death, up to 5 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
