NCT01483196

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	ultrasound imaging	Undergo TCD
OTHER	questionnaire administration	Complete neurocognitive questionnaires
PROCEDURE	assessment of therapy complications	Undergo TCD
PROCEDURE	quality-of-life assessment	Ancillary studies
PROCEDURE	magnetic resonance imaging	Undergo MRI

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-12-01
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States