Clinical trial · Observational
Breast Cancer & Antiestrogenic Therapy & Brain
The Impact of Anti-estrogenic Therapy in Breast Cancer Patients on Brain Architecture, Psychosexual Health, and Quality of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-estrogenic Therapy | — | UNRESOLVED | — |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Healthy Female | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (4)
- label
- premenopausal women diagnosed with breast cancer
- description
- receiving anti-estrogenic therapy
- interventionNames
- Drug: Tamoxifen
- label
- postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy
- description
- receiving anti-estrogenic therapy
- interventionNames
- Drug: Letrozole
- Drug: Letrozole + GnRH
- label
- premenopausal healthy women
- description
- before menopause
- label
- postmenopausal healthy women with/out previous hormonal replacement therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available