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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00205 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 01915A | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (MRI and CPET) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary Exercise Testing | Other | Undergo CPET |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult women with breast cancer or age-matched control
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| Name | Affiliation | Role |
|---|---|---|
| William Hundley | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| Magnetic Resonance Imaging | Device | Undergo MRI |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| C039811 | Clostridium perfringens epsilon-toxin |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
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