Clinical trial · Interventional
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)
NCT01483196CI-TRIAL-00033565completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| ultrasound imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (TCD)
- description
- 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.
- interventionNames
- Procedure: ultrasound imaging
- Other: questionnaire administration
- Procedure: assessment of therapy complications
- Procedure: quality-of-life assessment
- Procedure: magnetic resonance imaging
Primary outcomes (2)
- measure
- Participation rate
- timeFrame
- Over 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.