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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200226046624N1

Enrollment

Registered

2020-03-07

Start date

2018-03-21

Completion date

Unknown

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gliobalstom multiforme. Malignant neoplasm of brain, unspecified

Interventions

Intervention 1: Intervention group: Routine treatment (including phenytoin, dexamethasone and cefazolin) plus three dimethyl fumarate tablets (240 mg daily) one week before surgery. Intervention 2: Co

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiayesh Mohebbi

Tehran University of Medical Sciences

nmohebbi@tums.ac.ir+98 21 8490 2380

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026