Cognitive Side Effects of Cancer Therapy, Hypoestrogenism
Conditions
Keywords
breast cancer, cognitive side effects, hypoestrogenism, ovarian function suppression, aromatase inhibitor
Brief 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.
Interventions
DIAGNOSTIC_TESTvalidated questionnaires
Validated questionnaires for climacteric symptoms
DIAGNOSTIC_TESTfunctional MRI
functional MRI
DIAGNOSTIC_TESTOptical Coherent Tomography Angiography
OCT angiography, macular and peripapillary scans
Sponsors
University of Genova
Ospedale Policlinico San Martino
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive assessment | Once, at enrollment. | The principal aim of this project is to investigate the cognitive function of breast cancer patients that use Aromatase Inhibitors, comparing it with age-matched healthy controls, utilizing cognitive assessment and fMRI. * neuropsychological battery composed of the i) prose recall test, ii) trail making test A and B, iii) digit span backward and forward and iv) the symbol digit modalities test * 3T MRI (Siemens Prisma): 3D sagittal T2-FLAIR; 3D MP2RAGE; T2\* gradient echo-planar imaging under resting condition; twice-refocused spin echo echo-planar imaging sequence for multi-shell diffusion-weighted images |
Countries
Italy
Contacts
Primary ContactClaudia Massarotti, Dr
Outcome results
None listed