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

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.

NCT Number	NCT06606535
Lead Sponsor	Ospedale Policlinico San Martino Collaborators: University of Genova
Conditions	Cognitive Side Effects of Cancer Therapy, Hypoestrogenism
Enrollment	60 participants
Start Date	2024-06-13
Primary Completion	2025-04 (estimated)
Study Completion	2025-06-01 (estimated)
Updated on ClinicalTrials.gov	2024-09-23