Cognitive Function After Radiation Therapy for Brain Tumours
- Conditions
- Primary Brain TumorRadiation 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
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The participant must be 18 years or older and Danish speaking.
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Performance status 0-2
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Capable of cooperating on testing
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Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016
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ZM93803 glioma (exclusive glioblastoma)
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ZM9401/3 anaplastic astrocytoma, IDH mutant
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ZM9400/3 diffuse astrocytoma, IDH-mutant
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ZM9411/3 gemistocytisk astrocytoma, IDH mutant
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ZM9400/3 diffuse astrocytoma, NOS
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ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
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ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
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ZM9450/3 oligodendroglioma, NOS
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ZM9451/3 anaplastic oligodendroglioma, NOS
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ZM9530/0 meningioma
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ZM9470/3 medulloblastoma, NOS
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DD352A pituitary adenoma
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Other rare brain tumours including skull base sarcomas
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Performance status 3-4 Progression after radiation therapy
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radiotherapy group Cognitive testing Patients receiving radiotherapy after surgery for brain tumor No radiotherapy group Cognitive testing Patients NOT receiving radiotherapy after surgery for brain tumor
- Primary Outcome Measures
Name Time Method 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 function 1-10 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
Name Time Method Global Health - Quality of life 1-10 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 function 1-10 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 quality 1-10 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/Anxiety 1-10 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
Fatigue 1-10 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