Cognitive Function After Radiation Therapy for Brain Tumours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Memory impairment (as assessed by the HVLT-r)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Performance status 3-4 Progression after radiation therapy
结局指标
主要结局
Memory impairment (as assessed by the HVLT-r)
时间窗: 1-10 years after treatment
To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.
Neurocognitive function
时间窗: 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".
次要结局
- Global Health - Quality of life(1-10 years after treatment)
- Patients assessment of own cognitive function(1-10 years after treatment)
- Sleep quality(1-10 years after treatment)
- Depression/Anxiety(1-10 years after treatment)
- Fatigue(1-10 years after treatment)
研究者
Morten Høyer
Professor
University of Aarhus