<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/NCT03778008</url>
  </required_header>
  <id_info>
    <org_study_id>HL003</org_study_id>
    <nct_id>NCT03778008</nct_id>
  </id_info>
  <brief_title>Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis</brief_title>
  <official_title>Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis：An Open, Randomized, Controlled, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Nanchang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation therapy is one of the treatments for Nasopharyngeal carcinoma . The most common&#xD;
      side effects of post-radiation may be radiation-induced oral mucositis . When severe, oral&#xD;
      mucositis increases the risk of infection and may affect clinical outcomes due to treatment&#xD;
      interruption, dose reduction, and reduced treatment compliance. In China, a quadruple mixture&#xD;
      of dexamethasone, gentamicin, vitamin B12, and lidocaine is commonly used in patients who&#xD;
      begin to have radiation-induced oral mucositis . However, the incidence of radiation-induced&#xD;
      oral mucositis remains high. Recombinant bovine basic fibroblast growth factor is a&#xD;
      multifunctional cell growth factor that stimulates the growth of cells derived from mesoderm&#xD;
      and neuroectodermal cells and thus has a wide range of biological activities. The drug has&#xD;
      different degrees of promotion on the three stages of the wound repair process, namely the&#xD;
      local inflammatory reaction stage, cell proliferation and differentiation, granulation tissue&#xD;
      formation stage and tissue reconstruction stage. The purpose of this randomized controlled&#xD;
      trial was to evaluate the efficacy of recombinant bovine basic fibroblast growth factor as an&#xD;
      intervention in radiation-induced oral mucositis for the treatment of nasopharyngeal&#xD;
      carcinoma , with a commonly used quadruple mixture (from dexamethasone, gentamicin , vitamin&#xD;
      B12 and lidocaine composition) were compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 21, 2018</start_date>
  <completion_date type="Anticipated">December 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of grade ≥ 3 mucositis</measure>
    <time_frame>Day 56 after completion or termination of radiotherapy</time_frame>
    <description>Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>Day 56 after completion or termination of radiotherapy</time_frame>
    <description>EORTC QLQ-C30 is a Quality-of-Life Instrument proposed by the European Organization for Research and Treatment of Cancer (EORTC), for use in International Clinical Trials in Oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WHO score</measure>
    <time_frame>Day 56 after completion or termination of radiotherapy</time_frame>
    <description>The World Health Organization (WHO) Oral Toxicity score combines both elements into a single score that grades the severity of the condition from 0 (no oral mucositis) to 4 (swallowing not possible such that patient needs supplementary nutrition).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OMDQ MTS question 2 (Q2) score</measure>
    <time_frame>Day 56 after completion or termination of radiotherapy</time_frame>
    <description>Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) is a 5-point categorical scale in which patients grade MTS from 0 (no soreness) to 4 (extreme soreness)3 which is a component of the OMDQ in that it tracks very well with objective (WHO score and opioid use) and subjective measurement of OM severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OMAS</measure>
    <time_frame>Day 56 after completion or termination of radiotherapy</time_frame>
    <description>Oral Mucositis Assessment Scale (OMAS) provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Stomatitis</condition>
  <arm_group>
    <arm_group_label>Recombinant bovine basic fibroblast growth factor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadruple mixture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant bovine basic fibroblast growth factor</intervention_name>
    <description>Recombinant bovine basic fibroblast growth factor is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of recombinant bovine basic fibroblast growth factor at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade &gt; 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.</description>
    <arm_group_label>Recombinant bovine basic fibroblast growth factor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition</intervention_name>
    <description>Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade &gt; 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.</description>
    <arm_group_label>Quadruple mixture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically confirmed and previously untreated nasopharyngeal carcinoma&#xD;
&#xD;
          2. Age ≥ 18 years and ≤ 65 years.&#xD;
&#xD;
          3. Karnofsky performance status (KPS) score ≥ 70&#xD;
&#xD;
          4. Planned to receive radiotherapy alone or concurrent chemoradiotherapy&#xD;
&#xD;
          5. Adequate bone marrow function: while blood cell &gt;= 3,000/μL, absolute neutrophil count&#xD;
             &gt;= 1,500/μL, hemoglobin &gt;= 100g/L, platelet &gt;= 75,000/μL.&#xD;
&#xD;
          6. Life expectancy of &gt;= 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 years old or older than 70 years old&#xD;
&#xD;
          2. Pregnancy or lactation&#xD;
&#xD;
          3. Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes&#xD;
&#xD;
          4. Have suffered from oral diseases or salivary gland diseases or mow suffering from oral&#xD;
             diseases or salivary gland diseases&#xD;
&#xD;
          5. Refuse to give up smoking/drinking/betel chewing&#xD;
&#xD;
          6. suffering from other active infection diseases and in need of treatment.&#xD;
&#xD;
          7. Known allergic reaction to any component of Recombinant Bovine Basic Fibroblast Growth&#xD;
             Factoor or quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin&#xD;
             B12, and lidocaine, or severe allergic constitution.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>long Huang, PhD</last_name>
    <phone>13699549060</phone>
    <email>ndefy13211@ncu.edu.cn</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation therapy</keyword>
  <keyword>Nasopharyngeal carcinoma</keyword>
  <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>Vitamin B 12</mesh_term>
    <mesh_term>Gentamicins</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Mitogens</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03778008
org study id: HL003
nct id: NCT03778008
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Radiation therapy is one of the treatments for Nasopharyngeal carcinoma . The most common
      side effects of post-radiation may be radiation-induced oral mucositis . When severe, oral
      mucositis increases the risk of infection and may affect clinical outcomes due to treatment
      interruption, dose reduction, and reduced treatment compliance. In China, a quadruple mixture
      of dexamethasone, gentamicin, vitamin B12, and lidocaine is commonly used in patients who
      begin to have radiation-induced oral mucositis . However, the incidence of radiation-induced
      oral mucositis remains high. Recombinant bovine basic fibroblast growth factor is a
      multifunctional cell growth factor that stimulates the growth of cells derived from mesoderm
      and neuroectodermal cells and thus has a wide range of biological activities. The drug has
      different degrees of promotion on the three stages of the wound repair process, namely the
      local inflammatory reaction stage, cell proliferation and differentiation, granulation tissue
      formation stage and tissue reconstruction stage. The purpose of this randomized controlled
      trial was to evaluate the efficacy of recombinant bovine basic fibroblast growth factor as an
      intervention in radiation-induced oral mucositis for the treatment of nasopharyngeal
      carcinoma , with a commonly used quadruple mixture (from dexamethasone, gentamicin , vitamin
      B12 and lidocaine composition) were compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of grade ≥ 3 mucositis
time frame: Day 56 after completion or termination of radiotherapy
description: Incidence of grade ≥ 3 mucositis according to CTCAE version 5.0
measure: EORTC QLQ-C30
time frame: Day 56 after completion or termination of radiotherapy
description: EORTC QLQ-C30 is a Quality-of-Life Instrument proposed by the European Organization for Research and Treatment of Cancer (EORTC), for use in International Clinical Trials in Oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
measure: WHO score
time frame: Day 56 after completion or termination of radiotherapy
description: The World Health Organization (WHO) Oral Toxicity score combines both elements into a single score that grades the severity of the condition from 0 (no oral mucositis) to 4 (swallowing not possible such that patient needs supplementary nutrition).
measure: OMDQ MTS question 2 (Q2) score
time frame: Day 56 after completion or termination of radiotherapy
description: Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) is a 5-point categorical scale in which patients grade MTS from 0 (no soreness) to 4 (extreme soreness)3 which is a component of the OMDQ in that it tracks very well with objective (WHO score and opioid use) and subjective measurement of OM severity.
measure: OMAS
time frame: Day 56 after completion or termination of radiotherapy
description: Oral Mucositis Assessment Scale (OMAS) provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth.
arm group label: Recombinant bovine basic fibroblast growth factor
arm group type: Experimental
arm group label: Quadruple mixture
arm group type: Active Comparator
description: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
intervention type: Drug
intervention name: Recombinant bovine basic fibroblast growth factor
description: Recombinant bovine basic fibroblast growth factor is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of recombinant bovine basic fibroblast growth factor at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
arm group label: Recombinant bovine basic fibroblast growth factor
intervention type: Combination Product
intervention name: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition
description: Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
arm group label: Quadruple mixture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: long Huang, PhD
phone: 13699549060
email: ndefy13211@ncu.edu.cn
responsible party type: Sponsor
mesh term: Mucositis
mesh term: Stomatitis
mesh term: Vitamin B 12
mesh term: Gentamicins
mesh term: Dexamethasone
mesh term: Lidocaine
mesh term: Mitogens