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RECRUITING
NCT06606535

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

Sponsor: Ospedale Policlinico San Martino

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

validated questionnaires

Validated questionnaires for climacteric symptoms

DIAGNOSTIC_TEST

functional MRI

functional MRI

DIAGNOSTIC_TEST

Optical Coherent Tomography Angiography

OCT angiography, macular and peripapillary scans

Locations (1)

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy