Cerebral Morbidity After Radiation Therapy for Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Impairment of memory as assessed by the HVLT-r test
研究概览
简要总结
This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. 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 we need to spare, to prevent cognitive dysfunction.
The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. 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.
This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older and Danish speaking.
- •Performance status WHO 0-2
- •Capable of cooperating on testing
- •Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas
排除标准
- •Glioblastoma
- •Performance status 3-4
结局指标
主要结局
Impairment of memory as assessed by the HVLT-r test
时间窗: 5 Years
Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)
次要结局
- Verbal fluency(5 Years)
- Processing speed(5 Years)
- Executive function(5 Years)
- Verbal learning and memory(5 Years)
- Fatigue(5 years)
- Qulity of Sleep(5 years)
- Depression/Anxiety(5 years)
- Global Health - Quality of life(5 Years)
- Patient's Assessment of Own Functioning Inventory(5 years)
- Attention and working memory(5 Years)
研究者
Morten Høyer
Professor
University of Aarhus