Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · Comprehensive Cancer Center of Wake Forest University
NIH
observational
33
1 country
1
Study Start
August 25, 2016
Actual (reported)Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2016
Actual (reported)March 9, 2016
Actual (reported)August 25, 2016
Actual (reported)August 2017
Actual (reported)August 2017
Actual (reported)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
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.
Undergo CPET
Undergo MRI
Adult women with breast cancer or age-matched control
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
William Hundley
Wake Forest University Health Sciences
33 participants (actual enrollment reported by the registry).
First Submitted
March 1, 2016
First Posted
March 9, 2016
Study Start
August 25, 2016
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)Last Updated
April 26, 2019
Record last verified: 2018-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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