The Impact of Anti-estrogenic Therapy in Breast Cancer Patients on Brain Architecture, Psychosexual Health, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Correlations between antiestrogen hormone therapy and brain function & structure
研究概览
简要总结
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.
详细描述
If participants qualify for the current study, the investigators will invite them to the laboratory (T0), where participants will provide written, informed consent. Subsequently, the investigators will conduct a standardized clinical interview to screen for mental disorders (SCID-5-CV). Participants will also be informed about the study procedure. After the interview, participants will receive a password-protected link by email to access an online survey that measures, among other things, depressive symptoms, personality traits, gender identity and norms, relationship quality, sexual health, state and trait anxiety, and verbal intelligence.
All fMRI measurements (T1 and T2) will precede the hormonal and surgical components of the breast cancer treatment. Biopsy and analysis of tumor tissue will be performed in the pathology department of the University of Tuebingen Women's Clinic. Similarly, clinical routine procedures and adjuvant systemic treatment will be administered at the University of Tuebingen Women's Clinic.
Following the first interview, participants will undergo the first MRI session (T1) before starting anti-estrogenic therapy. The second MRI session (T2) will be scheduled two- three weeks after commencing anti-estrogenic therapy and before the surgery.
For controls, premenopausal women and postmenopausal women who have stopped or never used hormone replacement therapy will be included. At the start of the MRI sessions, a 30ml blood draw will be performed by medically trained personnel. The investigators anticipate hormonal changes between T1 and T2 due to breast cancer treatment (anti-estrogenic therapy).
After the second measurement (T2), women diagnosed with breast cancer will be invited to the third online session (T3) to assess possible related changes in psychosexual health, body image, and quality of life through questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
premenopausal women diagnosed with breast cancer
receiving anti-estrogenic therapy
干预措施: Tamoxifen (Drug)
postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy
receiving anti-estrogenic therapy
干预措施: Letrozole (Drug)
postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapy
receiving anti-estrogenic therapy
干预措施: Letrozole + GnRH (Drug)
结局指标
主要结局
Correlations between antiestrogen hormone therapy and brain function & structure
时间窗: Measured twice 2-3 weeks apart; approx. 32 minutes each time
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
Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls
时间窗: Measured twice 2-3 weeks apart; approx. 32 minutes each time, with fMRI, Anatomical Scan and Diffusion tensor imagingDiffisuin
Any differences in brain structure between Breast Cancer Patients and Healthy control.
Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls
时间窗: Measured twice 2-3 weeks apart; approx. 17 minutes each time
Differences in reward processing between Breast Cancer Patients and Healthy control. Effort Allocation Task will be applied.
Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects
时间窗: Measured twice 2-3 weeks apart; approx. 17 minutes each time
Possible effects of antiestrogen hormone therapy on reward processing in pre- and postmenopausal women diagnosed with breast cancer. Effort Allocation Task will be applied.
次要结局
- 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)
- Correlation between antiestrogen hormone therapy and cognitive changes(Measured for 2-3 weeks: Patients performing both tasks for 2-3 weeks.)
- Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls(Measured two times: before treatment, within 2-3 weeks after treatment; approx 60 minutes each time)