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

Ospedale Policlinico San Martino

Status: Enrolling

Conditions: Hypoestrogenism; Cognitive Side Effects of Cancer Therapy

Treatments: Diagnostic Test: validated questionnaires; Diagnostic Test: functional MRI; Diagnostic Test: Optical Coherent Tomography Angiography

Study type: Observational

Funder types: Other

Identifiers

NCT06606535

DB id 13624 (Other Identifier)

ENDO-BRAIN

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

60 participants in 2 patient groups

Cases

Description:

Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)

Treatment:

Diagnostic Test: Optical Coherent Tomography Angiography

Diagnostic Test: functional MRI

Diagnostic Test: validated questionnaires

Controls

Description:

Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.

Treatment:

Diagnostic Test: Optical Coherent Tomography Angiography

Diagnostic Test: functional MRI

Diagnostic Test: validated questionnaires