<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200226046624N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-07</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>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</public_title>
      <acronym></acronym>
      <scientific_title>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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random listing of patients in groups is based on random blocks of 4, 6, and 8 and is centrally performed by the concealment officer and the person performing the randomization of each related group that unaware of intervention, Blinding description: Patients in both groups receive routine drug therapy, and the patient will be prescribed medications as before. Routine drug therapy includes phenytoin, dexamethasone, and cefazolin. Patients treated with dimethyl fumarate will receive three pills (240 mg/day) daily from one week before surgery in addition to routine treatments. The control group will go through the same procedure as the treatment group, with the exception of taking three dimethyl fumarate tablets per day that will not be prescribed in this group, and placebo tablets of the same form and other non-mainstream drugs (e.g., preservatives) will be received. The surgeon, patient, and statistical analyst will be blind to this procedure.</study_design>
      <phase>3</phase>
      <hc_freetext>Gliobalstom multiforme.</hc_freetext>
      <i_freetext>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: Control group: Routine treatment (including phenytoin, dexamethasone and cefazolin) plus three placebo tablets and non-mainstream drugs (such as the same preservatives) will be received one week before surgery.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niayesh Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospial, Jalal-e-Al-Ahmad Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2380</telephone>
        <email>nmohebbi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Khoshnevisan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospial, Jalal-e-Al-Ahmad Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2380</telephone>
        <email>akhoshnevisan@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C71.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of brain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Routine treatment (including phenytoin, dexamethasone and cefazolin) plus three dimethyl fumarate tablets (240 mg daily) one week before surgery</i_keyword>
      <i_keyword>Control group: Routine treatment (including phenytoin, dexamethasone and cefazolin) plus three placebo tablets and non-mainstream drugs (such as the same preservatives) will be received one week before surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Performance status. Timepoint: Before and 30 day after surgery. Method of measurement: Karnofsky score.</prim_outcome>
      <prim_outcome>S100 beta protein. Timepoint: Before and 48 hours  after surgery. Method of measurement: ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Drug adverse effects. Timepoint: During study period. Method of measurement: Physical exam and patient reports.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-17</approval_date>
        <contact_name>Research Ethics Committees of Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research and Technology, Sixth Floor, Qods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
