Clinical trial NCT01483196: Vascular and Cognitive Assessments in Patients With Breast Cancer Undergoing Chemotherapy After Surgery
Official title: Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies vascular and cognitive assessments in patients with breast cancer undergoing chemotherapy after surgery. Learning about vascular and cognitive function may help plan treatment and improve the quality of life of breast cancer patients. Transcranial Doppler ultrasound (TCD) may help study the side effects of chemotherapy in breast cancer patients and allow doctors to plan better treatment

Detailed description: PRIMARY OBJECTIVES:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation rate
timeFrame: Over 1 year
measure: Retention rate
timeFrame: Over 1 year
Secondary outcomes:
measure: Changes in flow-mediated dilation and aortic dilation that occur after adjuvant chemotherapy for breast cancer
timeFrame: Approximately 90 days
measure: Correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the FACT-Cog
timeFrame: approximately 90 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Klepin, MD
role: PRINCIPAL_INVESTIGATOR
References: