Actively Recruiting
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Led by Ospedale Policlinico San Martino · Updated on 2024-09-23
60
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
O
Ospedale Policlinico San Martino
Lead Sponsor
U
University of Genova
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breast cancer patients undergoing endocrine adjuvant therapy with AI, with or without GnRH agonists, depending on menopause status at diagnosis
- At least 18 years old
- Good comprehension of oral and written Italian language
You will not qualify if you...
- Incomplete ovarian suppression (cases)
- Previous cancers other than the currently treated breast cancer (cases)
- Known neurological or psychiatric disorders
- Use of hormonal contraception or hormonal replacement therapy (controls)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy, 16132
Actively Recruiting
Research Team
C
Claudia Massarotti, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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