Efficacy of dimethyl fumarate administration vs placebo on neurosurgical brain induced injury measured by S100 beta protein concentration and performance (Karnofsky scale) among glioblastoma multiform patient

Phase 3

Recruiting

• Conditions: Gliobalstom multiforme.; Malignant neoplasm of brain, unspecified; C71.9

• Registration Number: IRCT20200226046624N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 March 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance status. Timepoint: Before and 30 day after surgery. Method of measurement: Karnofsky score.;S100 beta protein. Timepoint: Before and 48 hours after surgery. Method of measurement: ELISA kit.

Secondary Outcome Measures

Name	Time	Method
Drug adverse effects. Timepoint: During study period. Method of measurement: Physical exam and patient reports.