Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-14
Brief Title:
Breast Cancer Antiestrogenic Therapy Brain
Sponsor:
International Research Training Group 2804
Organization:
International Research Training Group 2804
Study Overview
Official Title:
The Impact of Anti-estrogenic Therapy in Breast Cancer Patients on Brain Architecture Psychosexual Health and Quality of Life
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjectiveself-report data via questionnaires and a standardized interview physiologicalendocrine 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
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 Womens Clinic Similarly clinical routine procedures and adjuvant systemic treatment will be administered at the University of Tuebingen Womens 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 gono-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
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 Womens Clinic Similarly clinical routine procedures and adjuvant systemic treatment will be administered at the University of Tuebingen Womens 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 gono-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None