Assessment of Cognitive Functions in Patients Receiving Whole Brain Radiotherapy in Assiut University Hospitals.

October 15, 2024 updated by: Abdulrahman Mahmoud Bakri Ahmed
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients diagnosed with brain tumor primary or secondary receiving WBRT.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abdulrahman Mahmoud Bakri Ahmed

Investigators

  • Study Director: Ahmed Abdelrahman, professor of psychiatry, Assiut University
  • Study Director: Fadia Attiah, Lecturer of Neuropsychiatry, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cognition affection WBRT

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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