Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG)
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.
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).
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Defined as the proportion of patients who participate in the study divided by the number of eligible patients. An exact binomial confidence interval (CI) will be calculated for this estimate.
Over 1 year
Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|