Cognitive Function After Radiation Therapy for Brain Tumours

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Function After Radiation Therapy for Brain Tumours

Conditions
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Primary Brain Tumor, Radiation Toxicity

Intervention / Treatment
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* Radiation: Cognitive testing


Participation Criteria
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Eligibility Criteria
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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 ZM93803 glioma (exclusive glioblastoma) ZM9401/3 anaplastic astrocytoma, IDH mutant ZM9400/3 diffuse astrocytoma, IDH-mutant ZM9411/3 gemistocytisk astrocytoma, IDH mutant ZM9400/3 diffuse astrocytoma, NOS ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted ZM9450/3 oligodendroglioma, NOS ZM9451/3 anaplastic oligodendroglioma, NOS ZM9530/0 meningioma ZM9470/3 medulloblastoma, NOS DD352A pituitary adenoma Other rare brain tumours including skull base sarcomas - Exclusion Criteria: Performance status 3-4 Progression after radiation therapy -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiotherapy group<br>Patients receiving radiotherapy after surgery for brain tumor | Radiation: Cognitive testing<br>* Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires. 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) Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).<br>|
| No radiotherapy group<br>Patients NOT receiving radiotherapy after surgery for brain tumor | Radiation: Cognitive testing<br>* Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires. 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) Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory impairment (as assessed by the HVLT-r) | To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus. | 1-10 years after treatment | 
| Neurocognitive function | 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. | 1-10 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Health - Quality of life | 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 | 1-10 years after treatment | 
| Fatigue | 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 | 1-10 years after treatment | 
| Sleep quality | 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 | 1-10 years after treatment | 
| Depression/Anxiety | 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 | 1-10 years after treatment | 
| Patients assessment of own cognitive function | Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function | 1-10 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive function