Clinical trial · Observational
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Side Effects of Cancer Therapy | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Hypoestrogenism | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| functional MRI | Diagnostic Test | — | UNRESOLVED |
| Optical Coherent Tomography Angiography | Diagnostic Test | — | UNRESOLVED |
| validated questionnaires | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
- interventionNames
- Diagnostic Test: validated questionnaires
- Diagnostic Test: functional MRI
- Diagnostic Test: Optical Coherent Tomography Angiography
- label
- Controls
- description
- Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.
- interventionNames
- Diagnostic Test: validated questionnaires
- Diagnostic Test: functional MRI
- Diagnostic Test: Optical Coherent Tomography Angiography
Primary outcomes (1)
- measure
- cognitive assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (2)
- BACKGROUNDMenning S, de Ruiter MB, Veltman DJ, Boogerd W, Oldenburg HS, Reneman L, Schagen SB. Changes in brain activation in breast cancer patients depend on cognitive domain and treatment type. PLoS One. 2017 Mar 7;12(3):e0171724. doi: 10.1371/journal.pone.0171724. eCollection 2017. PMID 28267750
- BACKGROUNDChen X, He X, Tao L, Li J, Wu J, Zhu C, Yu F, Zhang L, Zhang J, Qiu B, Yu Y, Wang K. The Working Memory and Dorsolateral Prefrontal-Hippocampal Functional Connectivity Changes in Long-Term Survival Breast Cancer Patients Treated with Tamoxifen. Int J Neuropsychopharmacol. 2017 May 1;20(5):374-382. doi: 10.1093/ijnp/pyx008. PMID 28177081