<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/NCT03788499</url>
  </required_header>
  <id_info>
    <org_study_id>XQonc-009</org_study_id>
    <nct_id>NCT03788499</nct_id>
  </id_info>
  <brief_title>Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis</brief_title>
  <official_title>Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinqiao Hospital of Chongqing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinqiao Hospital of Chongqing</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>
      A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were&#xD;
      randomly assigned to two groups. The experimental group was given massage of maxillofacial&#xD;
      and oral cavity plus routine oral care and functional exercise. The control group was given&#xD;
      routine oral care and functional exercise. Analyze the difference of incidence of severe&#xD;
      acute radioactive oral mucositis in these two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a&#xD;
      1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus&#xD;
      routine oral care and functional exercise, the control group was only given routine oral care&#xD;
      and functional exercise. Assess the condition of oral mucosa, according to the grading&#xD;
      standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy,&#xD;
      follow up the condition of oral mucosa one time per month for a total three times. Then&#xD;
      analyze the incidence difference between two groups.&#xD;
&#xD;
      massage method：The duration of the massage lasts from the first day of radiotherapy to three&#xD;
      months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch,&#xD;
      dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the&#xD;
      upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard&#xD;
      palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time.&#xD;
      Patients who could finished at least 75% are included in the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Anticipated">February 27, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 27, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of severe radioactive oral mucositis</measure>
    <time_frame>From the first day of radiotherapy to 3 months after the end of radiotherapy</time_frame>
    <description>the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.</measure>
    <time_frame>From the first day of radiotherapy to 3 months after the end of radiotherapy</time_frame>
    <description>the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine oral care and functional exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Massage arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage of Maxillofacial and Oral Cavity</intervention_name>
    <description>Massage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.</description>
    <arm_group_label>Massage arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed by pathology with nasopharyngeal carcinoma;&#xD;
&#xD;
          2. ECOG PS: 0-2;&#xD;
&#xD;
          3. Gender is not limited, Age between 18 years old and 70 years old.&#xD;
&#xD;
          4. Clear consciousness, no mental illness or cognition impairment;&#xD;
&#xD;
          5. The expected survival time is more than 12 months;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with other severe diseases affecting the quality of life or the treatment&#xD;
             process;&#xD;
&#xD;
          2. Unwilling to actively cooperate with investigators;&#xD;
&#xD;
          3. Patients with previous oral diseases;&#xD;
&#xD;
          4. Patients who have received head and neck surgery and radiotherapy;&#xD;
&#xD;
          5. A history of psychotropic substance abuse or a mental disorder;&#xD;
&#xD;
          6. Participated in clinical trials of other anti-tumor drugs within 4 weeks before&#xD;
             enrollment;&#xD;
&#xD;
          7. Women who are pregnant or in lactation;&#xD;
&#xD;
          8. Other situations that may affect the results of the clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xinqiao Hospital of Chongqing</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sun Jianguo</last_name>
      <email>yanmaizhixiang@sina.cn</email>
    </contact>
    <contact_backup>
      <phone>023774490</phone>
      <phone_ext>0086</phone_ext>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>the second affiliated hospital of Army medical university</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>40037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jianguo sun, Phd</last_name>
      <phone>023-68774490</phone>
      <email>sunjg09@aliyun.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 12, 2020</last_update_submitted>
  <last_update_submitted_qc>January 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinqiao Hospital of Chongqing</investigator_affiliation>
    <investigator_full_name>Jianguo Sun</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Massage</keyword>
  <keyword>Maxillofacial and Oral Cavity</keyword>
  <keyword>Radioactive Oral Mucositis</keyword>
  <keyword>Nasopharyngeal Carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Stomatitis</mesh_term>
  </condition_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/NCT03788499
org study id: XQonc-009
nct id: NCT03788499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were
      randomly assigned to two groups. The experimental group was given massage of maxillofacial
      and oral cavity plus routine oral care and functional exercise. The control group was given
      routine oral care and functional exercise. Analyze the difference of incidence of severe
      acute radioactive oral mucositis in these two groups.
160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a
      1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus
      routine oral care and functional exercise, the control group was only given routine oral care
      and functional exercise. Assess the condition of oral mucosa, according to the grading
      standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy,
      follow up the condition of oral mucosa one time per month for a total three times. Then
      analyze the incidence difference between two groups.

      massage method：The duration of the massage lasts from the first day of radiotherapy to three
      months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch,
      dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the
      upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard
      palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time.
      Patients who could finished at least 75% are included in the statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of severe radioactive oral mucositis
time frame: From the first day of radiotherapy to 3 months after the end of radiotherapy
description: the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.
measure: the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
time frame: From the first day of radiotherapy to 3 months after the end of radiotherapy
description: the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.
arm group label: Control arm
arm group type: No Intervention
description: routine oral care and functional exercise.
arm group label: Massage arm
arm group type: Experimental
description: Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise
intervention type: Other
intervention name: Massage of Maxillofacial and Oral Cavity
description: Massage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.
arm group label: Massage arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinqiao Hospital of Chongqing
investigator full name: Jianguo Sun
investigator title: Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Mucositis
mesh term: Stomatitis