Breast Cancer & Antiestrogenic Therapy & Brain

NCT06346457 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2024-04-04

No results posted yet for this study

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

Interventions

DRUG

Tamoxifen

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

DRUG

Letrozole

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

DRUG

Letrozole + GnRH

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • University Hospital Tuebingen

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • International Research Training Group 2804

    lead OTHER

Principal Investigators

  • Birgit Derntl, Prof · Department of Psychiatry & Psychotherapy, University of Tuebingen

  • Sara Brucker, Prof · Department of Women's Health University Women's Clinic

  • Markus Hahn, Prof · Department of Women's Health University Women's Clinic

  • Anna Wikman, Prof · Department of Women's and Children's Health, Reproductive Health

  • Ann Christin Kimmig, Dr · Department of Psychiatry & Psychotherapy, University of Tuebingen

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-12-01
Completion
2026-04-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346457 on ClinicalTrials.gov