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

Recruiting

• Conditions: Cognitive Side Effects of Cancer Therapy; Hypoestrogenism
• Interventions: Diagnostic Test: validated questionnaires; Diagnostic Test: functional MRI; Diagnostic Test: Optical Coherent Tomography Angiography

• Registration Number: NCT06606535
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-13
• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-04
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	validated questionnaires	Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
Cases	functional MRI	Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
Cases	Optical Coherent Tomography Angiography	Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
Controls	validated questionnaires	Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.
Controls	functional MRI	Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.
Controls	Optical Coherent Tomography Angiography	Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.

Primary Outcome Measures

Name	Time	Method
cognitive assessment	Once, at enrollment.	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

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, GE, Italy