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NCT Number: NCT06606535

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

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.

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Key information

Conditions

Cognitive Side Effects of Cancer Therapy Breast Diseases Breast Neoplasms Hypoestrogenism Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location status: Recruiting

Location contact

Claudia Massarotti, Dr

CONTACT

[email protected]

0039 + 0105555845

Claudia Massarotti, Dr

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

validated questionnaires

Diagnostic Test

Validated questionnaires for climacteric symptoms

Functional MRI

Diagnostic Test

functional MRI

Optical Coherent Tomography Angiography

Diagnostic Test

OCT angiography, macular and peripapillary scans

Other names: OCT angiography

Primary outcomes

  1. cognitive assessment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Massarotti, Dr

CONTACT

[email protected]

0039 + 0105555845

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Collaborators

  • University of Genova

Registry information

Acronym: ENDO-BRAIN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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