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ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Sponsor: Ospedale Policlinico San Martino
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2024-06-13
Completion Date
2025-06-01
Last Updated
2024-09-23
Healthy Volunteers
Yes
Interventions
validated questionnaires
Validated questionnaires for climacteric symptoms
functional MRI
functional MRI
Optical Coherent Tomography Angiography
OCT angiography, macular and peripapillary scans
Locations (1)
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy