Vascular and Cognitive Assessments in Patients With Breast Cancer Undergoing Chemotherapy After Surgery
NCT ID: NCT01483196
Last Updated: 2018-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-01-31
2014-05-31
Brief Summary
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Detailed Description
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I. To assess the feasibility of enrolling women who are receiving adjuvant chemotherapy for breast cancer to a clinical trial with assessments of vascular function and cognition before and after adjuvant chemotherapy and to obtain pilot data on outcomes that will be used in future larger-scale trials.
SECONDARY OBJECTIVES:
I. Evaluate the presence, duration, and severity of brain circulation changes identified with transcranial Doppler ultrasound (TCD) after adjuvant chemotherapy for breast cancer.
II. Assess the changes in flow-mediated dilation (FMD) and aortic dilation that occur after adjuvant chemotherapy for breast cancer.
III. Assess for correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog).
OUTLINE:
Patients undergo TCD examination including bilateral evaluation of standard intracranial arterial segments including the M1 and M2 segments of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) and posterior (PCA) cerebral artery, via the transtemporal acoustic windows, the internal carotid artery (ICA) siphon via transorbital approach, and the vertebral and basilar arteries (proximal, mid, and distal) via the suboccipital approach. Patients also undergo magnetic resonance imaging (MRI). All tests occur between 21 days after completion of surgery and up to 30 days prior to adjuvant chemotherapy and between 20-60 days after completion of adjuvant chemotherapy.
After completion of study treatment, patients are followed up periodically.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (TCD)
Patients undergo TCD examination including bilateral evaluation of standard intracranial arterial segments including the M1 and M2 segments of the MCA, the ACA and PCA, via the transtemporal acoustic windows, the ICA siphon via transorbital approach, and the vertebral and basilar arteries (proximal, mid, and distal) via the suboccipital approach. Patients also undergo MRI. All tests occur between 21 days after completion of surgery and up to 30 days prior to adjuvant chemotherapy and between 20-60 days after completion of adjuvant chemotherapy.
ultrasound imaging
Undergo TCD
questionnaire administration
Complete neurocognitive questionnaires
assessment of therapy complications
Undergo TCD
quality-of-life assessment
Ancillary studies
magnetic resonance imaging
Undergo MRI
Interventions
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ultrasound imaging
Undergo TCD
questionnaire administration
Complete neurocognitive questionnaires
assessment of therapy complications
Undergo TCD
quality-of-life assessment
Ancillary studies
magnetic resonance imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be candidates for either neoadjuvant or adjuvant chemotherapy for breast cancer
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Patients who are scheduled to receive trastuzumab and/or bevacizumab are not eligible
* Patients who are on dialysis
* Women who are pregnant are not eligible due to unknown risks and potential harm to the unborn fetus
* Patients with metastatic breast cancer are not eligible
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Heidi Klepin, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2011-02361
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 74111
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00017948
Identifier Type: -
Identifier Source: org_study_id
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