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Breast Cancer FemaleNCT06346457

Breast Cancer & Antiestrogenic Therapy & Brain

An observational study of Breast Cancer Female and Healthy Female, run by International Research Training Group 2804 at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer Female, Healthy Female, Menopause
What is being tested?
Tamoxifen, Letrozole and Letrozole + GnRH
Type of treatment
Injection or infusion
How many people
180 participants
Where
1 siteGermany
Study dates
1 Apr 2024to 1 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

Official title: The Impact of Anti-estrogenic Therapy in Breast Cancer Patients on Brain Architecture, Psychosexual Health, and Quality of Life

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.

Read the detailed description

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.

The investigators have meticulously planned the sequence of our MRI measurements to ensure a comprehensive exploration of various aspects of brain structure and function. The protocol is structured as follows:

  1. Anatomical Scan: The session begins with an anatomical scan, aiming to provide detailed insights into the structural aspects of the brain. This foundational step allows for a precise understanding of the anatomical features before delving into functional assessments.
  2. Resting State: Following the anatomical scan, participants will engage in a resting-state session lasting approximately 10 minutes. During this period, participants will watch a video to capture diverse facets of brain function and physiological states during rest. Resting-state measurements provide valuable information about intrinsic brain activity in the absence of a specific task.
  3. Effort Allocation Task (EAT): Subsequent to the resting-state session, participants will undertake the effort allocation task (EAT). This task is strategically designed to explore the trade-off between the benefits of effort and the associated costs. Participants will be involved in a task where monetary points are at stake, requiring physical effort by manipulating a grip-force measuring device. The payoff will be proportional to the duration of their invested effort. The EAT is anticipated to last up to 17 minutes.
  4. Diffusion Tensor Imaging (DTI): Following the EAT, participants will undergo Diffusion Tensor Imaging (DTI) to examine and map the white matter tracts in the brain. DTI is a sophisticated imaging technique that provides insights into the microstructural organization of white matter pathways, offering valuable information about connectivity.

This sequential approach from anatomical scanning to resting state, effort allocation task, and DTI is designed to systematically investigate both the structural and functional aspects of the brain in our study participants. The combination of these different imaging modalities enables a comprehensive understanding of the neural dynamics associated with anatomical structures, intrinsic brain activity at rest, responses to effortful tasks, and the organization of white matter tracts.

To comprehensively investigate self-report changes, the investigators will administer several questionnaires designed to assess various aspects. These questionnaires will focus on body image, psychosexual health, cancer-related quality of life changes, dyadic adjustment scale, well-being, and positive and negative affect changes. The data will be collected and managed through Redcap, providing a systematic and secure platform for organizing and analyzing participant responses. This approach ensures a thorough exploration of subjective experiences and enables a nuanced understanding of the psychological and emotional impact of the variables under investigation.

To thoroughly investigate cognitive changes, the investigators will use a home-testing battery. Participants will perform two online tasks: a reinforcement-learning risk sensitivity task and a gamified Pavlovian go/no-go task with varied bandits. Both tasks will be conducted weekly for three weeks, totaling approximately 1 hour. Data will be stored at the Quantitative Biology Center (QBiC) at the University of Tuebingen.

Being tested
Tamoxifen, Letrozole, Letrozole + GnRH
Keywords
Women´s mental health, Breast cancer, Anti-estrogenic therapy, Neuroimaging(fMRI), Estrogen, Menopause, Reward processing, Psychosexual health, Quality of life (QoL), MRI
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

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

  • LetrozoleDrug

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

  • Letrozole + GnRHDrug

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

Study groups in NCT06346457
Study groupRoleWhat they receive
premenopausal women diagnosed with breast cancerreceiving anti-estrogenic therapy
Receives: Drug: Tamoxifen
postmenopausal women diagnosed with breast cancer, with/out previous hormonal replacement therapyreceiving anti-estrogenic therapy
Receives: Drug: Letrozole; Drug: Letrozole + GnRH
premenopausal healthy womenbefore menopause
postmenopausal healthy women with/out previous hormonal replacement therapyafter menopause

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

  5. Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls

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

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

Secondary outcomes (6)
  1. Correlation between antiestrogen hormone therapy and psychosexual health

    Possible effects of antiestrogen hormone therapy on psychosexual health in pre- and postmenopausal women diagnosed with breast cancer.

    Questionnaires: Body Image Scale, Female Sexual Function Index

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

  2. Correlation between antiestrogen hormone therapy and quality of life

    Possible effects of antiestrogen hormone therapy on quality of life in pre- and postmenopausal women diagnosed with breast cancer.

    Questionnaires:European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire, Positive and Negative Affect Schedule

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

  3. Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls

    Differences in Psychosexual health between Breast Cancer Patients and Healthy control.

    Questionnaires: Female Sexual Function Index

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

  4. Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls

    Differences in Psychosexual health between Breast Cancer Patients and Healthy control.

    Questionnaires: Body Image Scale

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

  5. Correlation between antiestrogen hormone therapy and cognitive changes

    Possible effects of antiestrogen hormone therapy on cognitive changes in pre- and postmenopausal women diagnosed with breast cancer. It has two different behavioral tasks measured by home battery testing: a reinforcement-learning risk sensitivity task and a Pavlovian go/no-go task.

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

  6. Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls

    Differences in quality of life between Breast Cancer Patients and Healthy control. It measured with questionnaires.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346457
Sponsor's protocol ID
IRTG_P08
Status last verified
Mar 2024
First submitted
14 Feb 2024
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Female and Healthy Female, run by International Research Training Group 2804 at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Birgit Derntl, Prof. (0049 07071 2985437, birgit.derntl@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlations between antiestrogen hormone therapy and brain function & structure (time frame: Measured twice 2-3 weeks apart; approx. 32 minutes each time). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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