ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Recruiting · NCT06606535 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ospedale Policlinico San Martino
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where it is running
1 location listed.
- IRCCS Ospedale Policlinico San Martino - Genova, GE, Italy