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

Wake Forest University (WFU)

Status: Completed

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

Treatments: Device: Magnetic Resonance Imaging; Other: Cardiopulmonary Exercise Testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02702830

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2016-00205 (Registry Identifier)

CCCWFU 01915A (Other Identifier)

IRB00036572

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Diagnostic (MRI and CPET)

Description:

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.

Treatment:

Device: Magnetic Resonance Imaging

Other: Cardiopulmonary Exercise Testing