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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Contact Information
Primary
Claudia Massarotti, Dr
claudia.massarotti@unige.it
0039 + 0105555845
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 60
Treatments
Cases
Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
Controls
Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.
Related Therapeutic Areas
Sponsors
Collaborators: University of Genova
Leads: Ospedale Policlinico San Martino

This content was sourced from clinicaltrials.gov