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

NCT06606535 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Genova

    collaborator OTHER

  • Ospedale Policlinico San Martino

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-04-30
Completion
2025-06-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606535 on ClinicalTrials.gov