ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
NCT ID: NCT06606535
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-06-13
2025-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)
validated questionnaires
Validated questionnaires for climacteric symptoms
functional MRI
functional MRI
Optical Coherent Tomography Angiography
OCT angiography, macular and peripapillary scans
Controls
Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.
validated questionnaires
Validated questionnaires for climacteric symptoms
functional MRI
functional MRI
Optical Coherent Tomography Angiography
OCT angiography, macular and peripapillary scans
Interventions
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validated questionnaires
Validated questionnaires for climacteric symptoms
functional MRI
functional MRI
Optical Coherent Tomography Angiography
OCT angiography, macular and peripapillary scans
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Good comprehension of oral and written Italian language
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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University of Genova
OTHER
Ospedale Policlinico San Martino
OTHER
Responsible Party
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Claudia Massarotti
Principal Investigator
Locations
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IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
Countries
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Central Contacts
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Facility Contacts
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Claudia Massarotti, Dr
Role: backup
References
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Menning 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.
Chen 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.
Other Identifiers
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DB id 13624
Identifier Type: OTHER
Identifier Source: secondary_id
ENDO-BRAIN
Identifier Type: -
Identifier Source: org_study_id
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