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Cognitive Function After Radiation Therapy for Brain Tumours

Cognitive Function After Radiation Therapy for Brain Tumours

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04118426
Acronym
WP-12-pre
Enrollment
104
Registered
2019-10-08
Start date
2017-02-07
Completion date
2018-04-12
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Brain Tumor, Radiation Toxicity

Keywords

Cognitive function

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.

Interventions

RADIATIONCognitive testing

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).

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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 \-

Exclusion criteria

Performance status 3-4 Progression after radiation therapy \-

Design outcomes

Primary

MeasureTime frameDescription
Memory impairment (as assessed by the HVLT-r)1-10 years after treatmentTo examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.
Neurocognitive function1-10 years after treatmentExamine 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

MeasureTime frameDescription
Sleep quality1-10 years after treatmentAssessed 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
Global Health - Quality of life1-10 years after treatmentAssessed 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 treatmentAssessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function
Depression/Anxiety1-10 years after treatmentAssessed 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 treatmentAssessed by questionnaire: FACIT-Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026