Comparison the efficacy of dimethyl fumarate administration vs placebo on neurosurgical brain induced injury measured by S100 beta protein concentration and performance (Karnofsky scale), in glioblastoma multiform patient operated in Shariati Hospital from 2018 to 2021

Tehran University of Medical Sciences0 个研究点目标入组 72 人开始时间: 待定最近更新: 2020年3月24日

适应症

试验速览

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•Newly diagnosed monofocal GBM with strong evidence of MRI T1+GAD and histology confirmed after surgery by an identical pathologist (WHO grade IV).
•Patients = 18 years
•Adequate activity of liver, kidney, bone marrow and coagulation system
•Contraceptive drug use
•Signing and obtaining informed consent for inclusion in the study

•History of acute or chronic disease with poor prognosis, autoimmune diseases, immunodeficiency with a history of previous cancer
•Any infection in the last 2 weeks that has caused hospitalization or treatment with antibiotics or antivirals
•Drug sensitivity to temozolomide, dimethyl fumarate, phenytoin, dexamethasone, and cefazolin
•A history of coagulating or bleeding disorders
•Previous GBM
•Pregnancy or lactation
•High liver enzymes (over twice the normal) and proteinuria (more than 150 mg daily)
•Patients with diagnosis mixed tumor after surgery based on their tumor pathology report.
•Initial WBC less than 3500 or lymphopenia below 500
•A history of immunological disorders (such as cancer, lymphoma, positive serologic testing, HIV or viral hepatitis) over the past 6 months
•Patients with poorly compliance and did not use the drug correctly before surgery.
•Tumor metastasis
•Other brain and non-brain tumors
•History of significant head trauma in the past three months
•Indication of GBM emergency surgery
•Psychosis and cognitive impairment
•A history of disability from other neurodegenerative diseases such as CVA and hemiparesis
•MRI contraindications

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