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Not yet recruiting NCT06646094

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

Observational Brain Tumors Treated by Whole Brain Radition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Brain Tumors Treated by Whole Brain Radition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Assessment of cognitive functions before and after WBRT. [Time frame: 6 months]
Secondary outcome measures (1)
  • Evaluation of differences in cognitive affection between primary and secondary brain lesions [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06646094 · Cognition affection WBRT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗