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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01483196
First received: October 21, 2011
Last updated: August 25, 2014
Last verified: August 2014

October 21, 2011
August 25, 2014
January 2012
January 2015   (final data collection date for primary outcome measure)
  • Participation rate [ Time Frame: Over 1 year ] [ Designated as safety issue: No ]
    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.
  • Retention rate [ Time Frame: Over 1 year ] [ Designated as safety issue: No ]
    Defined as the proportion of participating patients who complete measurements pre and post chemotherapy. An exact CI will also be calculated for this estimate.
Same as current
Complete list of historical versions of study NCT01483196 on ClinicalTrials.gov Archive Site
  • Changes in flow-mediated dilation and aortic dilation that occur after adjuvant chemotherapy for breast cancer [ Time Frame: Approximately 90 days ] [ Designated as safety issue: No ]
  • Correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the FACT-Cog [ Time Frame: approximately 90 days ] [ Designated as safety issue: No ]
  • Presence, duration, and severity of brain circulation changes identified with TCD after adjuvant chemotherapy [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Changes in flow-mediated dilation and aortic dilation that occur after adjuvant chemotherapy for breast cancer [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the FACT-Cog [ Time Frame: 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • 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
  • Procedure: ultrasound imaging
    Undergo TCD
    Other Names:
    • ultrasonography
    • ultrasound
    • ultrasound test
  • Other: questionnaire administration
    Complete neurocognitive questionnaires
  • Procedure: assessment of therapy complications
    Undergo TCD
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Procedure: magnetic resonance imaging
    Undergo MRI
    Other Names:
    • MRI
    • NMR imaging
    • NMRI
    • nuclear magnetic resonance imaging
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.
Interventions:
  • Procedure: ultrasound imaging
  • Other: questionnaire administration
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
  • Procedure: magnetic resonance imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
January 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01483196
CCCWFU 74111, NCI-2011-02361
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Julia Lawrence Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP