xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05982197</url>
    </required_header>
    <id_info>
      <org_study_id>705722</org_study_id>
      <nct_id>NCT05982197</nct_id>
    </id_info>
    <brief_title>Curcumin Gel On Radiation Induced Oral Mucositis</brief_title>
    <official_title>The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor &amp; Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Baghdad</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Baghdad</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical study is to investigate the effect of a curcuma longa oral gel&#xD;
        (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and&#xD;
        provide a context for understanding if there is a relationship between the curcumin clinical&#xD;
        effect and production of EGFs and IL8.&#xD;
  &#xD;
        Researchers will compare between curcumin group and standard treatment group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 3, 2023</start_date>
    <completion_date type="Actual">July 2, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Two groups A) curcuma longa oral gel group B) standard treatment group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Onset of radiation induced mucositis</measure>
      <time_frame>Assessment every week starting from first visit until the onset of mucositis (up to 2 months)</time_frame>
      <description>Onset (at which week) of radiation induced mucositis in relation to EGF and IL8</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in severity of radiation induced mucositis</measure>
      <time_frame>Assessment every week starting from first visit of radiation unit it completion (average of 2 months)</time_frame>
      <description>Change in severity (degree of illness) of radiation induced mucositis in relation to EGF &amp; IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Radiation-Induced Mucositis</condition>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>Curcuma longa oral gel group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard treatment group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Curcumin Gel</intervention_name>
      <description>Curcuma longa oral gel for prevention radiation induced oral mucositis</description>
      <arm_group_label>Curcuma longa oral gel group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Standard Preparation</intervention_name>
      <description>Standard preparation for prevention radiation induced oral mucositis</description>
      <arm_group_label>Standard treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients above 16 years having histopathologically confirmed cancer in head and neck&#xD;
               region who planned to have radiation with head and neck mask.&#xD;
  &#xD;
            -  Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5&#xD;
               days/week).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient with hodgkin lymphoma.&#xD;
  &#xD;
            -  Any allergy to curcumin or other condiments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nuclear medicine and radiation therapy hospital</name>
        <address>
          <city>Baghdad</city>
          <zip>10053</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Baghdad</investigator_affiliation>
      <investigator_full_name>sarah adnan abdul-jabbar</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Radiation induced oral mucositis</keyword>
    <keyword>Head and neck cancer</keyword>
    <keyword>Curcuma longa</keyword>
    <keyword>EGF</keyword>
    <keyword>IL8</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</mesh_term>
      <mesh_term>Mucositis</mesh_term>
      <mesh_term>Stomatitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Curcumin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05982197
  org study id: 705722
  nct id: NCT05982197
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical study is to investigate the effect of a curcuma longa oral gel
        (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and
        provide a context for understanding if there is a relationship between the curcumin clinical
        effect and production of EGFs and IL8.
  
        Researchers will compare between curcumin group and standard treatment group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups A) curcuma longa oral gel group B) standard treatment group
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Onset of radiation induced mucositis
  time frame: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
  description: Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
  measure: Change in severity of radiation induced mucositis
  time frame: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
  description: Change in severity (degree of illness) of radiation induced mucositis in relation to EGF & IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}
  arm group label: Curcuma longa oral gel group
  arm group type: Active Comparator
  arm group label: Standard treatment group
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Curcumin Gel
  description: Curcuma longa oral gel for prevention radiation induced oral mucositis
  arm group label: Curcuma longa oral gel group
  intervention type: Drug
  intervention name: Standard Preparation
  description: Standard preparation for prevention radiation induced oral mucositis
  arm group label: Standard treatment group
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: University of Baghdad
  investigator full name: sarah adnan abdul-jabbar
  investigator title: principal investigator
  mesh term: Head and Neck Neoplasms
  mesh term: Mucositis
  mesh term: Stomatitis
  mesh term: Curcumin