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

Stage IIIA Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483196
• Other study ID #: IRB00017948
• Secondary ID: NCI-2011-02361CC
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• 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

Intervention

Procedure:
• ultrasound imaging
Undergo TCD

Other:
• questionnaire administration
Complete neurocognitive questionnaires

Procedure:
• assessment of therapy complications
Undergo TCD
• quality-of-life assessment
Ancillary studies
• magnetic resonance imaging
Undergo MRI

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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