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/NCT06031012</url>
    </required_header>
    <id_info>
      <org_study_id>AFMMUChina-oral mucocitis</org_study_id>
      <nct_id>NCT06031012</nct_id>
    </id_info>
    <brief_title>Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis</brief_title>
    <official_title>Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Air Force Military Medical University, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Air Force Military Medical University, China</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to compare glutamine combined with thalidomide with glutamine alone&#xD;
        in preventing radiation-induced oral mucositis. The aim of this study is to answer whether&#xD;
        glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis.&#xD;
        Participants would be randomly divided into the two groups above mentioned.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Explore the therapeutic efficacy of Glutamine combined with Thalidomide as compared to&#xD;
        Glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint&#xD;
        is the median time to the onset of Grade II oral mucositis, defined as the number of days&#xD;
        from the start of radiation therapy to the occurrence of Grade II oral mucositis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>Phase 3</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Median time for the occurrence of Grade 2 radiation-induced oral mucositis</measure>
      <time_frame>during radiotherapy up to 4 weeks</time_frame>
      <description>Median time for the occurrence of Grade 2 radiation-induced oral mucositis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence rate of ≥grade 2 oral mucositis</measure>
      <time_frame>during radiotherapy up to 4 weeks</time_frame>
      <description>incidence rate of ≥grade 2 oral mucositis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>during radiotherapy up to 4 weeks</time_frame>
      <description>&lt;18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, &gt;23.9kg/m2 indicates obesity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QOL</measure>
      <time_frame>during radiotherapy up to 4 weeks</time_frame>
      <description>Out of a total of 60 points, a score less than 20 indicates extremely poor quality of life; 21-30 points indicates poor quality of life; 31-40 points indicates average quality of life; 41-50 points indicates relatively good quality of life; 51-60 points indicates good quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adverse effects</measure>
      <time_frame>during radiotherapy up to 4 weeks</time_frame>
      <description>adverse effects</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Mucositis Oral</condition>
    <arm_group>
      <arm_group_label>glutamine combined with thalidomide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.&#xD;
  Thalidomide: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take orally at 100mg, once every evening.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>glutamine alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>glutamine combined with thalidomide</intervention_name>
      <description>Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.</description>
      <arm_group_label>glutamine combined with thalidomide</arm_group_label>
      <other_name>GT group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>glutamine alone</intervention_name>
      <description>Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.</description>
      <arm_group_label>glutamine alone</arm_group_label>
      <other_name>G group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 to 75 years old;&#xD;
  &#xD;
            2. Patients with postoperative oral malignant tumors confirmed by pathological histology&#xD;
               or cytology and requiring radiotherapy;&#xD;
  &#xD;
            3. Patients who have received more than 45Gy of radiation in the oral area;&#xD;
  &#xD;
            4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1;&#xD;
  &#xD;
            5. Basic hematological indicators are normal: White blood cell count ≥ 4×10^9/L; Absolute&#xD;
               neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 90 g/L;&#xD;
  &#xD;
            6. Basic renal function is normal: Serum creatinine ≤ 1.5×ULN (Upper Limit of Normal) or&#xD;
               Creatinine Clearance Rate (CrCl) &gt; 60 mL/min (using the Cockcroft-Gault formula):&#xD;
  &#xD;
               For women: CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl) For men: CrCl =&#xD;
               (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl)&#xD;
  &#xD;
            7. Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate&#xD;
               Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN.&#xD;
  &#xD;
            8. Signed written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participated in another interventional clinical trial within the last 30 days;&#xD;
  &#xD;
            2. Patients with severe underlying oral diseases who cannot tolerate radiation therapy;&#xD;
  &#xD;
            3. Patients allergic to glutamine and thalidomide;&#xD;
  &#xD;
            4. Patients receiving secondary radiation therapy to the oral area;&#xD;
  &#xD;
            5. Pregnant women (confirmed by blood or urine HCG testing) or breastfeeding women, or&#xD;
               participants of childbearing age who are unwilling or unable to take effective&#xD;
               contraceptive measures (applicable to both male and female participants) until at&#xD;
               least 6 months after the last trial treatment;&#xD;
  &#xD;
            6. Patients with underlying peripheral neuropathy;&#xD;
  &#xD;
            7. Individuals deemed by the researcher to be inappropriate for participation in this&#xD;
               study;&#xD;
  &#xD;
            8. Unwilling to participate in this study or unable to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
      <investigator_full_name>Mei Shi</investigator_full_name>
      <investigator_title>clinical professor of department of radiation oncology of XiJing hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>Thalidomide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06031012
  org study id: AFMMUChina-oral mucocitis
  nct id: NCT06031012
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to compare glutamine combined with thalidomide with glutamine alone
        in preventing radiation-induced oral mucositis. The aim of this study is to answer whether
        glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis.
        Participants would be randomly divided into the two groups above mentioned.
  Explore the therapeutic efficacy of Glutamine combined with Thalidomide as compared to
        Glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint
        is the median time to the onset of Grade II oral mucositis, defined as the number of days
        from the start of radiation therapy to the occurrence of Grade II oral mucositis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Median time for the occurrence of Grade 2 radiation-induced oral mucositis
  time frame: during radiotherapy up to 4 weeks
  description: Median time for the occurrence of Grade 2 radiation-induced oral mucositis
  measure: incidence rate of ≥grade 2 oral mucositis
  time frame: during radiotherapy up to 4 weeks
  description: incidence rate of ≥grade 2 oral mucositis
  measure: Body mass index
  time frame: during radiotherapy up to 4 weeks
  description: <18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity.
  measure: QOL
  time frame: during radiotherapy up to 4 weeks
  description: Out of a total of 60 points, a score less than 20 indicates extremely poor quality of life; 21-30 points indicates poor quality of life; 31-40 points indicates average quality of life; 41-50 points indicates relatively good quality of life; 51-60 points indicates good quality of life.
  measure: adverse effects
  time frame: during radiotherapy up to 4 weeks
  description: adverse effects
  arm group label: glutamine combined with thalidomide
  arm group type: Experimental
  description: L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.
  Thalidomide: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take orally at 100mg, once every evening.
  arm group label: glutamine alone
  arm group type: Active Comparator
  description: L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.
  intervention type: Drug
  intervention name: glutamine combined with thalidomide
  description: Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
  arm group label: glutamine combined with thalidomide
  other name: GT group
  intervention type: Drug
  intervention name: glutamine alone
  description: Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.
  arm group label: glutamine alone
  other name: G group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Air Force Military Medical University, China
  investigator full name: Mei Shi
  investigator title: clinical professor of department of radiation oncology of XiJing hospital
  mesh term: Mucositis
  mesh term: Stomatitis
  mesh term: Thalidomide
  sharing ipd: No