Brain Tumors Treated by Whole Brain RaditionNCT06646094
Assessment of Cognitive Functions in Patients Receiving Whole Brain Radiotherapy in Assiut University Hospitals.
An observational study of Brain Tumors Treated by Whole Brain Radition, run by Abdulrahman Mahmoud Bakri Ahmed.
Trial summary
Whole Brain Radiotherapy (WBRT) is widely used to manage brain metastases and primary brain tumors, but it frequently leads to cognitive decline, affecting patients' quality of life. Cognitive impairments after WBRT can manifest in various domains, including memory, attention, executive function, and processing speed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Tumors Treated by Whole Brain Radition
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients diagnosed with brain tumor primary or secondary receiving WBRT.
Who may be able to join
- • Adult patients (18 years or older)
- Patients diagnosed with brain metastases or primary brain tumor requiring WBRT.
- Ability to provide informed consent.
Who cannot join
- • Pre-existing severe cognitive impairments or psychiatric disorders unrelated to cancer treatment.
- Significant neurological conditions other than brain metastases.
- Patients unable or unwilling to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Whole Brain Radiotherapy (WBRT) is widely used to manage brain metastases and primary brain tumors, but it frequently leads to cognitive decline, affecting patients' quality of life. Cognitive impairments after WBRT can manifest in various domains, including memory, attention, executive function, and processing speed. These changes are attributed to direct radiation damage to neural tissues, particularly the hippocampus and white matter tracts, as well as secondary effects such as inflammation and vascular injury. Existing literature reports that up to 30% of patients may experience significant cognitive deterioration after WBRT, with the degree of impairment influenced by factors like total radiation dose, fractionation schedule, patient age, and baseline cognitive function. Despite these concerns, there is currently no standardized protocol for assessing cognitive changes in patients undergoing WBRT. Hippocampal avoidance and neuroprotective agents like memantine have shown potential in mitigating cognitive side effects, but their implementation remains inconsistent. Furthermore, routine cognitive assessments are not yet part of standard clinical practice, leading to a reactive rather than proactive approach to managing cognitive decline. This gap in early detection and standardized cognitive monitoring highlights the need for better methods to understand and manage the cognitive consequences of WBRT. Without systematic assessment, cognitive impairments may go unrecognized until they significantly impact daily functioning, emphasizing the importance of addressing this issue to better support patients undergoing whole brain radiotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cognitive functions before and after WBRT.
Assessing the cognitive function of the subjects using the Montreal Cognitive Assessment (MoCA) scale
Purpose: To provide a broader assessment of cognitive abilities, including attention, memory, language, visuospatial skills, and executive function.
Measured: 6 months
Secondary outcomes (1)
Evaluation of differences in cognitive affection between primary and secondary brain lesions
Assessing the cognitive function of the subjects using the Montreal Cognitive Assessment (MoCA) scale Purpose: To provide a broader assessment of cognitive abilities, including attention, memory, language, visuospatial skills, and executive function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumors Treated by Whole Brain RaditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdulrahman Mahmoud Bakri Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdulrahman Mahmoud Bakri Ahmed, Assiut University
- Investigators
- Ahmed Abdelrahman, professor of psychiatry, Study director, Assiut UniversityFadia Attiah, Lecturer of Neuropsychiatry, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646094
- Sponsor's protocol ID
- Cognition affection WBRT
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cognitive Functions in Patients Receiving Whole Brain Radiotherapy in Assiut University Hospitals.
- ClinicalTrials.gov ID
- NCT06646094
- Acronym / sponsor ID
- Cognition affection WBRT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abdulrahman Mahmoud Bakri AhmedUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whole Brain Radiotherapy (WBRT) is widely used to manage brain metastases and primary brain tumors, but it frequently leads to cognitive decline, affecting patients' quality of life. Cognitive impairments after WBRT can manifest in various domains, including memory, attention, executive function, and processing speed. These changes are attributed to direct radiation damage to neural tissues, particularly the hippocampus and white matter tracts, as well as secondary effects such as inflammation and vascular injury. Existing literature reports that up to 30% of patients may experience significant cognitive deterioration after WBRT, with the degree of impairment influenced by factors like total radiation dose, fractionation schedule, patient age, and baseline cognitive function. Despite these concerns, there is currently no standardized protocol for assessing cognitive changes in patients undergoing WBRT. Hippocampal avoidance and neuroprotective agents like memantine have shown potential in mitigating cognitive side effects, but their implementation remains inconsistent. Furthermore, routine cognitive assessments are not yet part of standard clinical practice, leading to a reactive rather than proactive approach to managing cognitive decline. This gap in early detection and standardized cognitive monitoring highlights the need for better methods to understand and manage the cognitive consequences of WBRT. Without systematic assessment, cognitive impairments may go unrecognized until they significantly impact daily functioning, emphasizing the importance of addressing this issue to better support patients undergoing whole brain radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with brain tumor primary or secondary receiving WBRT.
Key inclusion criteria (3 listed)
- • Adult patients (18 years or older)
Key exclusion criteria (3 listed)
- • Pre-existing severe cognitive impairments or psychiatric disorders unrelated to cancer treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of cognitive functions before and after WBRT.
Time frame: 6 months
Assessing the cognitive function of the subjects using the Montreal Cognitive Assessment (MoCA) scale Purpose: To provide a broader assessment of cognitive abilities, including attention, memory, language, visuospatial skills, and executive function.
1 secondary outcome
Evaluation of differences in cognitive affection between primary and secondary brain lesions
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Abdelrahman, professor of psychiatry study director
Assiut University
Fadia Attiah, Lecturer of Neuropsychiatry study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors Treated by Whole Brain Radition, run by Abdulrahman Mahmoud Bakri Ahmed.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Ahmed (+201018081871, AbdElrahman.15256899@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cognitive functions before and after WBRT. (time frame: 6 months). 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 17 Oct 2024.