NCT Number: NCT06646094
Assessment of Cognitive Functions in Patients Receiving Whole Brain Radiotherapy in Assiut University Hospitals.
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.
Trial opening soon.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- • Adult patients (18 years or older)
- Patients diagnosed with brain metastases or primary brain tumor requiring WBRT.
- Ability to provide informed consent.
Exclusion criteria
- • 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.
Treatment and study plan
Primary outcomes
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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.
Secondary outcomes
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Evaluation of differences in cognitive affection between primary and secondary brain lesions
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Abdulrahman Mahmoud Bakri Ahmed
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Oct 17, 2024
- Registry last updated
- Oct 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.