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)

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

Study Overview

• Status: Completed
• Conditions: Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Cognitive/Functional Effects; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIIC Breast Cancer; Recurrent Breast Cancer
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: magnetic resonance imaging; Procedure: ultrasound imaging; Other: questionnaire administration; Procedure: assessment of therapy complications

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (TCD); 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.

Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: magnetic resonance imaging; Undergo MRI; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging; Procedure: ultrasound imaging; Undergo TCD; Other Names: ultrasonography; ultrasound; ultrasound test; Other: questionnaire administration; Complete neurocognitive questionnaires; Procedure: assessment of therapy complications; Undergo TCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate	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.	Over 1 year
Retention rate	Defined as the proportion of participating patients who complete measurements pre and post chemotherapy. An exact CI will also be calculated for this estimate.	Over 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heidi Klepin, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB00017948; NCI-2011-02361 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 74111 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No