RecruitingNCT06606535

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


Sponsor

Ospedale Policlinico San Martino

Enrollment

60 participants

Start Date

Jun 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether hormone therapy used after breast cancer treatment — specifically a class of drugs called aromatase inhibitors (AIs) — affects brain function and cognitive abilities such as memory, attention, and thinking speed. Researchers want to understand if these commonly prescribed medications cause noticeable changes in how patients think and feel. **You may be eligible if...** - You are a breast cancer patient currently receiving aromatase inhibitor therapy (with or without a GnRH agonist to suppress ovarian function) - You are at least 18 years old - You have a good understanding of written and spoken Italian **You may NOT be eligible if...** - Your ovarian suppression is incomplete (for cases) - You have had a previous cancer other than the current breast cancer - You have a known neurological or psychiatric disorder - You are taking hormonal contraceptives or hormone replacement therapy (for control group participants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTvalidated questionnaires

Validated questionnaires for climacteric symptoms

DIAGNOSTIC_TESTfunctional MRI

functional MRI

DIAGNOSTIC_TESTOptical Coherent Tomography Angiography

OCT angiography, macular and peripapillary scans


Locations(1)

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

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NCT06606535


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