Effects of Aromatase Inhibitors on Cognitive Function in Breast Cancer Patients
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
This study is testing how aromatase inhibitors affect thinking skills in breast cancer patients compared to healthy people their age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ospedale Policlinico San Martino Academic / other |
| Locations | 1 site (Genova, GE) |
| Trial ID | NCT06606535 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the cognitive function of breast cancer patients undergoing endocrine adjuvant therapy with aromatase inhibitors, comparing their performance to age-matched healthy controls. The study will utilize cognitive assessments and functional magnetic resonance imaging (fMRI) to evaluate cognitive function and its correlation with estrogen deprivation symptoms. Additionally, the research will assess endothelial damage using Angio Optical Coherent Tomography (angio OCT). Patients will be recruited during follow-up visits at an outpatient clinic, and data will be collected through validated questionnaires and assessments performed by trained staff.
Who should consider this trial
Good fit: Ideal candidates include breast cancer patients aged 18 and older who are undergoing endocrine adjuvant therapy with aromatase inhibitors.
Not a fit: Patients with incomplete ovarian suppression, previous neoplastic diseases, known neurological or psychiatric disorders, or those using hormonal contraception or replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the cognitive side effects of breast cancer treatment, potentially leading to improved management strategies for affected patients.
How similar studies have performed: While there may be studies exploring cognitive effects of cancer therapies, this specific approach combining cognitive assessments with fMRI and angio OCT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Genova, GE
- IRCCS Ospedale Policlinico San Martino — Genova, Ge, Italy (Recruiting)
Study contacts
- Study coordinator: Claudia Massarotti, Dr
- Email: claudia.massarotti@unige.it
- Phone: 0039 + 0105555845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.