Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
The Centre for Clinical Trials Lübeck, Lübeck, Germany.
BMC Cancer. 2021 Apr 9;21(1):386. doi: 10.1186/s12885-021-08121-y.
Gliomas are often associated with symptoms including seizures. Most patients with high-grade gliomas are treated with radiotherapy or radio-chemotherapy. Since irradiation causes inflammation, it may initially aggravate symptoms. Studies focusing on seizure activity during radiotherapy for gliomas are not available. Such knowledge may improve patient monitoring and anti-epileptic treatment. This study evaluates seizure activity during radiotherapy for high-grade gliomas.
The primary objective this prospective interventional study is the evaluation of seizure activity during a course of radiotherapy for high-grade gliomas. Progression of seizure activity is defined as increased frequency of seizures by > 50%, increased severity of seizures, or initiation/increase by ≥25% of anti-epileptic medication. Seizure frequency up to 6 weeks following radiotherapy and electroencephalography activity typical for epilepsy will also be evaluated. Patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, they will document number (and type) of seizures and anti-epileptic medication. Once a week, the findings of the diary are checked and discussed with a neurologist to initiate or adjust anti-epileptic medication, if necessary. Patients complete a questionnaire regarding their satisfaction with the seizure diary. If the dissatisfaction rate is > 40%, the seizure diary will be considered not suitable for the investigated indication. Thirty-five patients (32 patients plus drop-outs) should be enrolled. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with progression of seizure activity is 30% (rate under the alternative hypothesis), assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis).
If an increase in seizure activity during a course of radiotherapy for high-grade glioma occurs, the findings of this study may pave the way for a larger prospective trial and will likely lead to closer patient monitoring and better anti-epileptic treatment.
clinicaltrials.gov ( NCT04552756 ); registered on 16th of September, 2020.
脑胶质瘤常伴有癫痫等症状。大多数高级别脑胶质瘤患者接受放疗或放化疗。由于照射会引起炎症，因此可能会最初加重症状。目前尚无针对脑胶质瘤放疗期间癫痫发作活动的研究。此类知识可能会改善患者的监测和抗癫痫治疗。本研究评估了高级别脑胶质瘤放疗期间的癫痫发作活动。
这项前瞻性干预研究的主要目的是评估高级别脑胶质瘤放疗过程中的癫痫发作活动。癫痫发作活动的进展定义为癫痫发作频率增加>50%、癫痫发作严重程度增加或抗癫痫药物增加≥25%。还将评估放疗后 6 周内的癫痫发作频率和典型的癫痫脑电图活动。患者在放疗期间和放疗后 6 周内保留癫痫发作日记。每天记录癫痫发作次数（和类型）和抗癫痫药物。每周一次，由神经病学家检查日记记录并进行讨论，以根据需要启动或调整抗癫痫药物。患者完成一份关于他们对癫痫发作日记满意度的问卷。如果不满意率>40%，则认为该癫痫发作日记不适合所研究的适应症。应招募 35 名患者（32 名患者加脱落者）。在这个样本量下，如果进展性癫痫发作的患者比例为 30%（替代假设下的率），单侧 2.5%显著性水平的单样本二项式检验的功效为 80%，以得出统计学意义，如果不进行放疗，假设无放疗（无效假设）的背景进展率为 10%，则有进展性癫痫发作的患者比例为 30%。
如果在高级别脑胶质瘤放疗过程中出现癫痫发作活动增加，本研究的结果可能为更大规模的前瞻性试验铺平道路，并可能导致更密切的患者监测和更好的抗癫痫治疗。
clinicaltrials.gov（NCT04552756）；注册于 2020 年 9 月 16 日。
