NCT06606535

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Side Effects of Cancer Therapy
• Hypoestrogenism

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-06-13
• Primary completion: 2025-04-01
• Completion: 2025-06-01
• First posted: 2024-09-23
• Last updated: 2024-09-23

Locations

1 site across 1 country: Italy