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
Conditions
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
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.
Interventions
PROCEDUREultrasound imaging
Undergo TCD
OTHERquestionnaire administration
Complete neurocognitive questionnaires
PROCEDUREassessment of therapy complications
Undergo TCD
PROCEDUREquality-of-life assessment
Ancillary studies
PROCEDUREmagnetic resonance imaging
Undergo MRI
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation rate | Over 1 year | 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 | Over 1 year | Defined as the proportion of participating patients who complete measurements pre and post chemotherapy. An exact CI will also be calculated for this estimate. |
Secondary
| 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 |
Countries
United States
Outcome results
None listed