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

Stage IIIA Breast Cancer Clinical Trial

Official title:

Understanding Exercise Intolerance After Treatment for Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702830
• Other study ID #: IRB00036572
• Secondary ID: NCI-2016-00205CC
• Status: Completed
• Start date: August 25, 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• 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

Other:
• Cardiopulmonary Exercise Testing
Undergo CPET

Device:
• Magnetic Resonance Imaging
Undergo MRI

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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