Journal Article

A prospective interventional study evaluating seizure activity during a radiotherapy course for high-grade gliomas (SURF-ROGG)

Olbrich, Denise, Trillenberg, Peter, Tvilsted, Soeren, Rades, Dirk, Schild, Steven E., Witteler, Jaspar, Kjaer, Troels W.

2021

Overview

Background 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. Methods 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). Discussion 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. Trial registration clinicaltrials.gov ( NCT04552756 ); registered on 16th of September, 2020.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Anticonvulsants - therapeutic use / Biomedical and Life Sciences / Biomedicine / Biopsy / Brain cancer / Brain Neoplasms - complications / Brain Neoplasms - pathology / Brain Neoplasms - radiotherapy / Cancer Research / Care and treatment / Chemoradiotherapy / Chemotherapy / Complications and side effects / Convulsions & seizures / Cranial Irradiation - adverse effects / Cranial Irradiation - methods / Diaries / Disease Management / Disease Susceptibility / EEG / Electroencephalography / Epilepsy / Female / Glioma / Glioma - complications / Glioma - pathology / Glioma - radiotherapy / Gliomas / Health Promotion and Disease Prevention / High-grade glioma / Humans / Hypotheses / Male / Medical and radiation oncology / Medicine/Public Health / Mutation / Neoplasm Grading / Neoplasm Staging / Oncology / Patient satisfaction / Questionnaires / Radiation therapy / Radio-chemotherapy / Radiotherapy / Risk factors / Seizure diary / Seizures / Seizures (Medicine) / Seizures - diagnosis / Seizures - etiology / Seizures - therapy / Study Protocol / Surgical Oncology / Symptom Assessment / Treatment Outcome