Clinical trial NCT02702830: MRI and Cardio-Pulmonary Exercise Testing in Evaluating Exercise Intolerance in Patients With Stage I-III Breast Cancer After Chemotherapy Treatment
Official title: Understanding Exercise Intolerance After Treatment for Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-09
Enrollment: 33
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with breast cancer or age-matched control

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: A-VO2 differences
timeFrame: Baseline to up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William Hundley
role: PRINCIPAL_INVESTIGATOR
References: