Breast Cancer & Antiestrogenic Therapy & Brain

NCT06346457 | Not Yet Recruiting

• 1 other identifier: IRTG_P08
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Female; Healthy Female; Menopause; Anti-estrogenic Therapy

Keywords

Women´s mental health; Breast cancer; Anti-estrogenic therapy; Neuroimaging(fMRI); Estrogen; Menopause; Reward processing; Psychosexual health; Quality of life (QoL); MRI

Outcome Measures

Primary Outcomes (5)

• Correlations between antiestrogen hormone therapy and brain function & structure

  Possible effects of antiestrogen hormone therapy on brain function (functional activation based on BOLD effect) and structure in pre- and postmenopausal women diagnosed with breast cancer. Anatomical scan, Resting state and Diffusion Tensor Imaging will be assessed

  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

  Possible effects of antiestrogen hormone therapy on reward processing in pre- and postmenopausal women diagnosed with breast cancer. Effort Allocation Task will be applied.

  Measured twice 2-3 weeks apart; approx. 17 minutes each time

• Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls

  Any differences in brain Function (functional activation based on BOLD effect) between Breast Cancer Patients and Healthy control

  Measured twice 2-3 weeks apart; approx. 32 minutes each time

• Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls

  Differences in reward processing between Breast Cancer Patients and Healthy control. Effort Allocation Task will be applied.

  Measured twice 2-3 weeks apart; approx. 17 minutes each time

• Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls

  Any differences in brain structure between Breast Cancer Patients and Healthy control.

  Measured twice 2-3 weeks apart; approx. 32 minutes each time, with fMRI, Anatomical Scan and Diffusion tensor imagingDiffisuin

Secondary Outcomes (6)

• Correlation between antiestrogen hormone therapy and psychosexual health

  Measured three times: before treatment, within 2-3 weeks after treatment and 6 months after treatment; approx 60 minutes each time

• Correlation between antiestrogen hormone therapy and quality of life

  Measured with questionnaires three times: before treatment, within 2-3 weeks after treatment and 6 months after treatment; approx 60 minutes each time

• Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls

  Measured two times: before treatment and within 2-3 weeks after treatment; approx 60 minutes each time

• Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls

  Measured two times: before treatment and within 2-3 weeks after treatment; approx 60 minutes each time

• Correlation between antiestrogen hormone therapy and cognitive changes

  Measured for 2-3 weeks: Patients performing both tasks for 2-3 weeks.

Study Arms (4)

premenopausal women diagnosed with breast cancer

receiving anti-estrogenic therapy

Drug: Tamoxifen

postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy

receiving anti-estrogenic therapy

Drug: Letrozole; Drug: Letrozole + GnRH

premenopausal healthy women

before menopause

postmenopausal healthy women with/out previous hormonal replacement therapy

after menopause

Interventions

Tamoxifen DRUG

Tamoxifen is 20 mg once daily for two to three weeks.

premenopausal women diagnosed with breast cancer

Letrozole DRUG

Letrozole (Aromatase inhibitor) is 2,5 mg once daily for two to three weeks.

postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy

Letrozole + GnRH DRUG

When they take Letrozole + GnRh, the GnRh is an injection once a month.

postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population (breast cancer patients and healthy control) will mainly consist of residents of Tübingen and surrounding areas.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• International Research Training Group 2804: lead
• German Research Foundation: collaborator
• University Hospital Tuebingen: collaborator
• Uppsala University: collaborator

Study Sites (1)

University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Letrozole; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Birgit Derntl, Prof

  Department of Psychiatry & Psychotherapy, University of Tuebingen

  PRINCIPAL INVESTIGATOR

• Sara Brucker, Prof

  Department of Women's Health University Women's Clinic

  PRINCIPAL INVESTIGATOR

• Markus Hahn, Prof

  Department of Women's Health University Women's Clinic

  PRINCIPAL INVESTIGATOR

• Anna Wikman, Prof

  Department of Women's and Children's Health, Reproductive Health

  PRINCIPAL INVESTIGATOR

• Ann Christin Kimmig, Dr

  Department of Psychiatry & Psychotherapy, University of Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Derntl, Prof.

CONTACT

0049 07071 2985437; birgit.derntl@med.uni-tuebingen.de

Serenay Yazici Sarikaya, M.Sc.

CONTACT

0049 07071 2962492; serenay.yazici.sarikaya@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)