NCT01483196

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

October 21, 2011

Last Update Submit

July 2, 2018

Conditions

Cognitive/Functional EffectsRecurrent Breast CancerStage IA Breast CancerStage IB Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Diagnostic (TCD)

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.

Procedure: ultrasound imagingOther: questionnaire administrationProcedure: assessment of therapy complicationsProcedure: quality-of-life assessmentProcedure: magnetic resonance imaging

Interventions

ultrasound imagingPROCEDURE

Undergo TCD

Also known as: ultrasonography, ultrasound, ultrasound test
Diagnostic (TCD)
questionnaire administrationOTHER

Complete neurocognitive questionnaires

Diagnostic (TCD)
assessment of therapy complicationsPROCEDURE

Undergo TCD

Diagnostic (TCD)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Diagnostic (TCD)
magnetic resonance imagingPROCEDURE

Undergo MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (TCD)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock WavesMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Heidi Klepin, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

December 1, 2011

Study Start

January 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)