Cognitive Side Effects of Cancer TherapyENDO-BRAINNCT06606535
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
An observational study of Cognitive Side Effects of Cancer Therapy and Hypoestrogenism, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Side Effects of Cancer Therapy, Hypoestrogenism
- What is being tested?
- validated questionnaires, functional MRI and Optical Coherent Tomography Angiography
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Claudia Massarotti, Dr, 0039 + 0105555845, claudia.massarotti@unige.it
Claudia Massarotti, Dr
About this study
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.
- Being tested
- validated questionnaires, functional MRI, Optical Coherent Tomography Angiography
- Keywords
- breast cancer, cognitive side effects, hypoestrogenism, ovarian function suppression, aromatase inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validated questionnairesDiagnostic test
Validated questionnaires for climacteric symptoms
functional MRIDiagnostic test
functional MRI
Optical Coherent Tomography AngiographyDiagnostic test
Also called OCT angiography
OCT angiography, macular and peripapillary scans
| Study group | Role | What they receive |
|---|---|---|
| Cases | Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal) Receives: 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. Receives: Diagnostic Test: validated questionnaires; Diagnostic Test: functional MRI; Diagnostic Test: Optical Coherent Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once, at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start13 Jun 2024
- Primary completionApr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Side Effects of Cancer TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova
- Responsible party
- Principal investigator, Claudia Massarotti, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606535
- Sponsor's protocol ID
- ENDO-BRAIN
- Other IDs
- DB id 13624
- Acronym
- ENDO-BRAIN
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28267750Chen 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.
PubMed 28177081
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06606535
- Acronym / sponsor ID
- ENDO-BRAIN / ENDO-BRAIN
- Keywords
- breast cancer, cognitive side effects, hypoestrogenism, ovarian function suppression, aromatase inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Collaborators
- University of Genova
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: validated questionnaires, Diagnostic Test: functional MRI, Diagnostic Test: Optical Coherent Tomography AngiographyBreast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal) |
| Controls | – | Diagnostic Test: validated questionnaires, Diagnostic Test: functional MRI, Diagnostic Test: Optical Coherent Tomography AngiographyHealthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| validated questionnairesValidated questionnaires for climacteric symptoms | Diagnostic test | Cases, Controls |
| functional MRIfunctional MRI | Diagnostic test | Cases, Controls |
| Optical Coherent Tomography AngiographyAlso: OCT angiographyOCT angiography, macular and peripapillary scans | Diagnostic test | Cases, Controls |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 28267750Menning 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.
- Background: PubMed 28177081Chen 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.
Related trials for Cognitive Side Effects of Cancer Therapy
RecruitingPhase 1/2
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Ovarian Cancer, Cognitive Impairment
Recruiting
Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients
Childhood Cancer, Cancer-related Problem/Condition
RecruitingObservational study
The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life
Cancer, Hearing Loss Ototoxic
Not yet recruiting
Cognitive Impairment in Treated Breast Cancer Survivors: Possible Approaches
Cognitive Impairment, Chemobrain
RecruitingPhase 2
Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
Cognitive Impairment, Cognitive Decline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Side Effects of Cancer Therapy and Hypoestrogenism, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Massarotti, Dr (0039 + 0105555845, claudia.massarotti@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive assessment (time frame: Once, at enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.