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Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG)

18 Years
Open (Enrolling)
Cognitive/Functional Effects, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed non-metastatic breast
cancer; stages 1-3 are acceptable

- 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 have had prior systemic chemotherapy are not eligible for the study

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Participation rate

Outcome Description:

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.

Outcome Time Frame:

Over 1 year

Safety Issue:


Principal Investigator

Julia Lawrence

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 74111



Start Date:

January 2012

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Recurrent Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157