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Cognitive Function After Radiation Therapy for Brain Tumours

Completed
Conditions
Primary Brain Tumor
Radiation Toxicity
Interventions
Radiation: Cognitive testing
Registration Number
NCT04118426
Lead Sponsor
University of Aarhus
Brief Summary

This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). All types of brain tumours apart from glioblastoma will be included

Detailed Description

RT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. There is modest knowledge on which parts of the brain the investigators need to spare, to prevent cognitive dysfunction.

The study is a cross sectional study assessing cognitive function in patients with brain tumours previously treated with RT compared to a similar non irradiated group. 104 patients with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016 will be included. The patients will do patient reported outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory Serial Addition Test (PASAT). The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
104
Inclusion Criteria
  • The participant must be 18 years or older and Danish speaking.

  • Performance status 0-2

  • Capable of cooperating on testing

  • Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016

    1. ZM93803 glioma (exclusive glioblastoma)

    2. ZM9401/3 anaplastic astrocytoma, IDH mutant

    3. ZM9400/3 diffuse astrocytoma, IDH-mutant

    4. ZM9411/3 gemistocytisk astrocytoma, IDH mutant

    5. ZM9400/3 diffuse astrocytoma, NOS

    6. ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted

    7. ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted

    8. ZM9450/3 oligodendroglioma, NOS

    9. ZM9451/3 anaplastic oligodendroglioma, NOS

    10. ZM9530/0 meningioma

    11. ZM9470/3 medulloblastoma, NOS

    12. DD352A pituitary adenoma

    13. Other rare brain tumours including skull base sarcomas

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Exclusion Criteria

Performance status 3-4 Progression after radiation therapy

  -
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Radiotherapy groupCognitive testingPatients receiving radiotherapy after surgery for brain tumor
No radiotherapy groupCognitive testingPatients NOT receiving radiotherapy after surgery for brain tumor
Primary Outcome Measures
NameTimeMethod
Memory impairment (as assessed by the HVLT-r)1-10 years after treatment

To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.

Neurocognitive function1-10 years after treatment

Examine correlations cognitive decline and subvolumes of the brain. Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP). Measures on cognitive test is time in seconds or number of "corrects".

Secondary Outcome Measures
NameTimeMethod
Global Health - Quality of life1-10 years after treatment

Assessed by questionnaire; EORTC QlQ-C30 in order to examine the level of quality of life in brain tumour patients who has received radiation therapy

Patients assessment of own cognitive function1-10 years after treatment

Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function

Sleep quality1-10 years after treatment

Assessed by questionnaire:Pittsburg Sleep Quality INDEX, PSQI in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy

Depression/Anxiety1-10 years after treatment

Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour

Fatigue1-10 years after treatment

Assessed by questionnaire: FACIT-Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy

Trial Locations

Locations (1)

Aarhus University Hospital

🇩🇰

Aarhus, Region Midt, Denmark

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