Clinical trial

The Impact of Anti-estrogenic Therapy in Breast Cancer Patients on Brain Architecture, Psychosexual Health, and Quality of Life

Name
IRTG_P08
Description
The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-12-01
Trial end
2026-04-01
Status
Not yet recruiting
Treatment
Tamoxifen
Tamoxifen is 20 mg once daily for two to three weeks.
Arms:
premenopausal women diagnosed with breast cancer
Letrozole
Letrozole (Aromatase inhibitor) is 2,5 mg once daily for two to three weeks.
Arms:
postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy
Letrozole + GnRH
When they take Letrozole + GnRh, the GnRh is an injection once a month.
Arms:
postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy
Size
180
Primary endpoint
Correlations between antiestrogen hormone therapy and brain function & structure
Measured twice 2-3 weeks apart; approx. 32 minutes each time
Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects
Measured twice 2-3 weeks apart; approx. 17 minutes each time
Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls
Measured twice 2-3 weeks apart; approx. 32 minutes each time
Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls
Measured twice 2-3 weeks apart; approx. 17 minutes each time
Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls
Measured twice 2-3 weeks apart; approx. 32 minutes each time, with fMRI, Anatomical Scan and Diffusion tensor imagingDiffisuin
Eligibility criteria
Inclusion Criteria: * Women before or after menopause * With/without a diagnosis of breast cancer * Between 18 and 70 years old * Body mass index 18-35 kg/m² * Fluent in written and spoken German * At least an intermediate school leaving certificate Exclusion Criteria: * Any neurological or mental disease based on standardized diagnoses confirmed via the structured clinical interview for DSM-5, Clinical Version (SCID-5-CV) * Women who gave birth or were breastfeeding within the last year * Participants with a history of sexual trauma or abuse * Participants taking any medication interfering with brain activation * Participants taking oral contraceptives * Male breast cancer patients * Patients with alcohol or substance abuse * Patients if the origin of the cancer is not in the breast cells * Patients have any other physical severe diseases (stroke, diabetes, heart attack, etc.) * Patients currently ongoing chemotherapy * Participants who did not consent Additional exclusion criteria for MRI: * People with non-removable metal objects on or in the body * Tattoos (if MRI-incompatible according to expert guidelines) * Pathological hearing or increased sensitivity to loud noises * Claustrophobia * Surgery less than three months ago * Moderate or severe head injury
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

2 products

1 drug

4 indications

Indication
Breast Cancer
Indication
Healthy Female
Indication
Menopause
Product
Letrozole