Vascular and Cognitive Assessments in Patients With Breast Cancer Undergoing Chemotherapy After Surgery

Wake Forest University (WFU)

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Recurrent Breast Cancer; Cognitive/Functional Effects

Treatments: Procedure: quality-of-life assessment; Procedure: magnetic resonance imaging; Procedure: ultrasound imaging; Procedure: assessment of therapy complications; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01483196

IRB00017948

CCCWFU 74111 (Other Identifier)

NCI-2011-02361 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Diagnostic (TCD)

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Procedure: assessment of therapy complications

Procedure: ultrasound imaging

Procedure: magnetic resonance imaging

Procedure: quality-of-life assessment