MRI and Cardio-Pulmonary Exercise Testing in Evaluating Exercise Intolerance in Patients With Stage I-III Breast Cancer After Chemotherapy Treatment

Study Overview
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Brief Summary
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This pilot research trial studies magnetic resonance imaging (MRI) and cardio (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines. Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also experience progressive fatigue and exercise intolerance which may limit daily activities and is an important barrier for patients returning to work. Using MRI and cardio-pulmonary exercise testing (CPET) may help doctors understand the causes of fatigue and exercise intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle function.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the feasibility of performing upright treadmill cardio-pulmonary exercise stress testing utilizing magnetic resonance imaging. II. To determine the reproducibility of measures of peak oxygen uptake (V02) and cardiac output as well as arterio-venous oxygen difference (A-V02) difference in survivors of breast cancer treatment and control participants. OUTLINE: Patients undergo CPET using a one-way breathing mask in 2 separate days 1-2 weeks apart. Patients also undergo MRI before and within 60 seconds after exercising.

Official Title
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Understanding Exercise Intolerance After Treatment for Cancer

Conditions
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Healthy Subject, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Other: Cardiopulmonary Exercise Testing
* Device: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with stage I-III breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy Women matched to age with our 16 post-cancer treatment participants Exclusion Criteria: Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices Those with contraindications for exercise tolerance test (ETT) testing, including unstable angina or inability to exercise on a treadmill or stationary cycle Those who are pregnant, claustrophobic, or unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (MRI and CPET)<br>Patients undergo CPET using a one-way breathing mask in 2 separate days 1-2 weeks apart. Patients also undergo MRI before and within 60 seconds after exercising. | Other: Cardiopulmonary Exercise Testing<br>* Undergo CPET<br>* Other names: CPX;Device: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A-VO2 differences | Descriptive statistics will be estimated for each measure at each of the two times they are measured. Correlation between the two assessments of each measure will be estimated and then establish a 95% confidence interval for this correlation. Difference between each assessment will be calculated and a 95% confidence interval for this difference will be estimated. A paired t-test will be performed to determine if the groups have a mean difference close to zero. The ratio of the variances for each measure at each time point will be examined. The ratio will be examined whether it is close to 1.0 | Baseline to up to 2 weeks |