An Observational Study on the Effects of Anti-Hormone Therapy for Breast Cancer on Brain Structure, Psychosexual Health, and Quality of Life
- Gender
- Women
- Age
- 18–70 years
- Trial type
- Observational
- Line of therapy
- all
- Phase
- —
What is this trial about?
For breast cancer with detectable hormone receptors on the cancer cells, anti-hormone therapy is an integral part of standard treatment; however, its effects on the brain and psychological well-being have not yet been sufficiently studied. The goal of this study is to investigate the impact of anti-hormone therapy on brain structure and function, psychosexual health (sexual well-being), and quality of life. Women between the ages of 18 and 70, with or without a diagnosis of breast cancer, are eligible to participate in this study.
Trial flow
Requirements
Diagnosis: breast cancer and healthy control subjects
Age: 18–70 years
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: hormone receptor positive; pre- or postmenopausal
Allocation
Stratifizierung anhand von Markern
Treatment
Follow-up
Diagnosis: breast cancer and healthy control subjects
Age: 18–70 years
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: hormone receptor positive; pre- or postmenopausal
Stratifizierung anhand von Markern
Detailed description
Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue in which cells multiply uncontrollably. Treatment depends on various factors, including the patient’s menopausal status, the biological characteristics of the tumor, and the presence of hormone receptors on the cancer cells. If the cancer cells are hormone receptor-positive, anti-hormone therapy can be used to inhibit hormone-dependent tumor growth. The medications used include tamoxifen (a selective estrogen receptor modulator, SERM) and letrozole (an aromatase inhibitor), which are taken as tablets, possibly in combination with a GnRH analog administered via injection. Although these therapies are part of standard treatment, little is currently known about how they affect the brain, psychosexual health, and patients’ quality of life.
The aim of this observational study is to investigate the impact of anti-hormone therapy on brain structure and function, sexual well-being, and quality of life. To this end, four different groups will be formed and compared with one another: premenopausal breast cancer patients receiving anti-hormone therapy, postmenopausal breast cancer patients receiving anti-hormone therapy, and one group each of premenopausal and postmenopausal healthy women as comparison groups. As part of the study, functional MRI (magnetic resonance imaging) scans of the brain will be performed at two time points (before and two to three weeks after the start of anti-hormone therapy). Among other things, these scans will examine brain structure, brain activity at rest, and reward behavior. In addition, blood samples will be collected to measure hormone levels, and participants will complete questionnaires on psychosexual health, body image, and quality of life. No new medications will be tested. Follow-up as part of the study will continue for up to six months after the start of therapy.
Women between the ages of 18 and 70, with or without a diagnosis of breast cancer, are eligible to participate in this study.
Facts
- Condition: Breast cancer (mammary carcinoma) as well as healthy control subjects
- Cancer characteristics: Anti-hormone therapy planned (tamoxifen or letrozole, possibly with a GnRH analog), pre- or postmenopausal
- What the study investigates: The effect of anti-hormone therapy on brain structure, brain function, psychosexual health, and quality of life
- Study objective: To gather new insights regarding the potential effects of anti-hormone therapy
- Study duration: Follow-up for up to six months after the start of treatment
- Study characteristics: Observational study, case-control design, open-label (unblinded), four comparison groups
Trial sites
1 trial site in Germany is listed.
Universitätsklinikum Tübingen
72076 Tübingen
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT06346457) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.