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.
Breast cancer patients undergoing endocrine adjuvant therapy with AI, with or without GnRH agonists, depending on menopause status at diagnosis (cases only)
At least 18 years old
Good comprehension of oral and written Italian language
incomplete ovarian suppression (cases)
previous neoplastic diseases other than the presently treated breast cancer for cases
known neurological or psychiatric disorders
use of hormonal contraception or hormonal replacement therapy (controls)
This is a monocentric study, taking place in an university hospital, which is a referral point for both oncology and neurology. Cases are recruited from the iatrogenic menopause outpatient clinic. This is a dedicated outpatient clinic for the gynecological follow up of cancer survivors, including breast cancer patients undergoing adjuvant endocrine therapy. It is part of the oncofertility pathway of the institution, it is run by doctors with specific expertise in reproductive endocrinology, fertility and menopause. The clinic is accessed by all patients, not only the symptomatic ones, for yearly follow ups. Healthy controls are recruited from the gynecological, neurological or ophthalmological outpatient clinics.
Case-control
Prospective
validated questionnaires
Diagnostic testValidated questionnaires for climacteric symptoms
functional MRI
Diagnostic testfunctional MRI
Optical Coherent Tomography Angiography
Diagnostic testOCT angiography, macular and peripapillary scans
cognitive assessment
The principal aim of this project is to investigate the cognitive function of breast cancer patients that use Aromatase Inhibitors, comparing it with age-matched healthy controls, utilizing cognitive assessment and fMRI. * neuropsychological battery composed of the i) prose recall test, ii) trail making test A and B, iii) digit span backward and forward and iv) the symbol digit modalities test * 3T MRI (Siemens Prisma): 3D sagittal T2-FLAIR; 3D MP2RAGE; T2\* gradient echo-planar imaging under resting condition; twice-refocused spin echo echo-planar imaging sequence for multi-shell diffusion-weighted images
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Ospedale Policlinico San Martino
Lead sponsor
University of Genova
Collaborator
