ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients

NCT06606535 | Recruiting

• 2 other identifiers: ENDO-BRAINDB id 13624
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Side Effects of Cancer Therapy; Hypoestrogenism

Keywords

breast cancer; cognitive side effects; hypoestrogenism; ovarian function suppression; aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• cognitive assessment

  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

  Once, at enrollment.

Study Arms (2)

Cases

Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)

Diagnostic Test: validated questionnaires; Diagnostic Test: functional MRI; Diagnostic Test: Optical Coherent Tomography Angiography

Controls

Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.

Diagnostic Test: validated questionnaires; Diagnostic Test: functional MRI; Diagnostic Test: Optical Coherent Tomography Angiography

Interventions

validated questionnaires DIAGNOSTIC_TEST

Validated questionnaires for climacteric symptoms

Cases; Controls

functional MRI DIAGNOSTIC_TEST

functional MRI

Cases; Controls

Optical Coherent Tomography Angiography DIAGNOSTIC_TEST

OCT angiography, macular and peripapillary scans

Also known as: OCT angiography

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a monocentric study, taking place in an university hospital, which is a referral point for both oncology and neurology. Cases are recruited from the iatrogenic menopause outpatient clinic. This is a dedicated outpatient clinic for the gynecological follow up of cancer survivors, including breast cancer patients undergoing adjuvant endocrine therapy. It is part of the oncofertility pathway of the institution, it is run by doctors with specific expertise in reproductive endocrinology, fertility and menopause. The clinic is accessed by all patients, not only the symptomatic ones, for yearly follow ups. Healthy controls are recruited from the gynecological, neurological or ophthalmological outpatient clinics.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead
• University of Genova: collaborator

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 28267750 BACKGROUND

• 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.

  PMID: 28177081 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Claudia Massarotti, Dr

CONTACT

0039 + 0105555845; claudia.massarotti@unige.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 23, 2024
• Study Start: June 13, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

IT (1)