Overview

This trial is active, not recruiting.

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
Treatments ultrasound imaging, questionnaire administration, assessment of therapy complications, quality-of-life assessment, magnetic resonance imaging
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date January 2012
End date May 2014
Trial size 30 participants
Trial identifier NCT01483196, CCCWFU 74111, NCI-2011-02361

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
ultrasound imaging ultrasonography
Undergo TCD
questionnaire administration
Complete neurocognitive questionnaires
assessment of therapy complications
Undergo TCD
quality-of-life assessment quality of life assessment
Ancillary studies
magnetic resonance imaging MRI
Undergo MRI

Primary Outcomes

Measure
Participation rate
time frame: Over 1 year
Retention rate
time frame: Over 1 year

Secondary Outcomes

Measure
Changes in flow-mediated dilation and aortic dilation that occur after adjuvant chemotherapy for breast cancer
time frame: Approximately 90 days
Correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the FACT-Cog
time frame: approximately 90 days

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG)
Principal investigator Heidi Klepin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.