ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients

Study acronym: ENDO-BRAIN
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated September 23, 2024 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use AI, comparing it with age-matched healthy controls, utilizing cognitive assessments and functional magnetic resonance imaging (fMRI). Additionally, the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms, including vasomotor symptoms, and to evaluate a possible correlation with endothelial damage studied through Angio Optical Coherent Tomography (angio OCT). Patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic. After informed consent, the will be asked for detailed demographic data, medical, oncological and gynecological history. Hypoestrogenism symptoms will be collected through validated questionnaires. The cognitive assessment will be performed on the same day, by trained staff. The fMRI and angioOCT will be booked and performed depending on patient and clinic availability.
Trial Details
NCT Number NCT06606535
Lead Sponsor Ospedale Policlinico San Martino
Collaborators: University of Genova
Conditions
(from sponsor)
Cognitive Side Effects of Cancer Therapy, Hypoestrogenism
Related terms Breast Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov