<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/NCT03302676</url>
  </required_header>
  <id_info>
    <org_study_id>S-20160053</org_study_id>
    <nct_id>NCT03302676</nct_id>
  </id_info>
  <brief_title>The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors</brief_title>
  <official_title>The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense Patient Data Explorative Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a&#xD;
      salivary stimulant for head and neck cancer patients treated with curative intended&#xD;
      radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation-induced xerostomia and hyposalivation are frequent side effects after completed&#xD;
      treatment for oral and oropharyngeal cancers. This may induce eating and swallowing&#xD;
      difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a&#xD;
      consequence, quality of life is often impaired for this group of patients even after&#xD;
      completing treatment.&#xD;
&#xD;
      This study hypothesize that chewing gum can stimulate salivary flow from the residual&#xD;
      functional salivary glands and thereby improving the patient's oral well-being.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      - To assess whether the difference between the unstimulated and stimulated salivary flow&#xD;
      after a one-month period of using chewing gum will result in improved oral well-being.&#xD;
&#xD;
      Secondary endpoint:&#xD;
&#xD;
        -  To assess if unstimulated and stimulated salivary flow differs between the two groups of&#xD;
           patients&#xD;
&#xD;
        -  To evaluate changes in quality of life with EORTC QLQ H&amp;N-35 for patients using chewing&#xD;
           gum&#xD;
&#xD;
        -  To evaluate differences in quality of life with EORTC QLQ H&amp;N-35 between the two groups&#xD;
           of patients.&#xD;
&#xD;
      All patients who have received curative intended treatment for oral or oropharyngeal&#xD;
      carcinomas at the Department of Oncology, Odense University Hospital, will be invited to&#xD;
      participate in the study. If the eligibility criteria are met the patient will be randomized&#xD;
      2:1 to either the intervention arm with chewing gum or the control arm with standard oral&#xD;
      care. The study intends to include 210 patients in total. Of these, 140 patients in the&#xD;
      intervention arm and 70 in the control arm. Recruitment to the study was initiated in&#xD;
      September 2016 and is expected to be completed in July 2018.&#xD;
&#xD;
      The duration of the study is one month from inclusion and randomization to final follow up.&#xD;
      For all included patients, saliva samples are collected (unstimulated and stimulated&#xD;
      sialometry) and the EORTC QLQ H&amp;N-35 questionnaire and a xerostomia specific questionnaire&#xD;
      are completed. The patients in the control arm are only introduced to chewing gum at the last&#xD;
      follow up visit. In the intervention arm, all patients are instructed to use the chewing gum&#xD;
      on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document&#xD;
      compliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">September 2018</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>2:1 randomization in favor of chewing gum (intervention)</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary flow (intervention arm)</measure>
    <time_frame>1 month</time_frame>
    <description>Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary flow (both groups of patients)</measure>
    <time_frame>1 month</time_frame>
    <description>The difference between unstimulated and stimulated salivary flow will be higher for patients in the intervention arm as compared to the difference in salivary flow for patients in the control arm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Radiation Therapy Complication</condition>
  <condition>Xerostomia</condition>
  <condition>Hyposalivation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month.&#xD;
Daily registrations in a patient dairy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chewing gum</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Diagnosed with oral or oropharyngeal carcinoma&#xD;
&#xD;
          -  Received curative intended radiation therapy (primary or postoperative), 60-66Gy&#xD;
             including concurrent chemotherapy&#xD;
&#xD;
          -  Within 6 to 60 months after radiation therapy&#xD;
&#xD;
          -  Complains of xerostomia level 1 (according to Danish Head and Neck Cancer group)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor teeth condition or full set of dentures&#xD;
&#xD;
          -  Recurrence of cancer or palliative treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie K Kaae, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Danmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Julie Killerup Kaae</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Saliva substitute</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03302676
org study id: S-20160053
nct id: NCT03302676
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a
      salivary stimulant for head and neck cancer patients treated with curative intended
      radiotherapy.
Radiation-induced xerostomia and hyposalivation are frequent side effects after completed
      treatment for oral and oropharyngeal cancers. This may induce eating and swallowing
      difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a
      consequence, quality of life is often impaired for this group of patients even after
      completing treatment.

      This study hypothesize that chewing gum can stimulate salivary flow from the residual
      functional salivary glands and thereby improving the patient's oral well-being.

      Primary endpoint:

      - To assess whether the difference between the unstimulated and stimulated salivary flow
      after a one-month period of using chewing gum will result in improved oral well-being.

      Secondary endpoint:

        -  To assess if unstimulated and stimulated salivary flow differs between the two groups of
           patients

        -  To evaluate changes in quality of life with EORTC QLQ H&N-35 for patients using chewing
           gum

        -  To evaluate differences in quality of life with EORTC QLQ H&N-35 between the two groups
           of patients.

      All patients who have received curative intended treatment for oral or oropharyngeal
      carcinomas at the Department of Oncology, Odense University Hospital, will be invited to
      participate in the study. If the eligibility criteria are met the patient will be randomized
      2:1 to either the intervention arm with chewing gum or the control arm with standard oral
      care. The study intends to include 210 patients in total. Of these, 140 patients in the
      intervention arm and 70 in the control arm. Recruitment to the study was initiated in
      September 2016 and is expected to be completed in July 2018.

      The duration of the study is one month from inclusion and randomization to final follow up.
      For all included patients, saliva samples are collected (unstimulated and stimulated
      sialometry) and the EORTC QLQ H&N-35 questionnaire and a xerostomia specific questionnaire
      are completed. The patients in the control arm are only introduced to chewing gum at the last
      follow up visit. In the intervention arm, all patients are instructed to use the chewing gum
      on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document
      compliance.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2:1 randomization in favor of chewing gum (intervention)
primary purpose: Supportive Care
masking: None (Open Label)
measure: Salivary flow (intervention arm)
time frame: 1 month
description: Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.
measure: Salivary flow (both groups of patients)
time frame: 1 month
description: The difference between unstimulated and stimulated salivary flow will be higher for patients in the intervention arm as compared to the difference in salivary flow for patients in the control arm.
arm group label: Intervention
arm group type: Active Comparator
description: Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month.
Daily registrations in a patient dairy.
arm group label: Control
arm group type: No Intervention
description: Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
intervention type: Dietary Supplement
intervention name: Chewing gum
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie K Kaae, MD
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Julie Killerup Kaae
investigator title: M.D.
mesh term: Oropharyngeal Neoplasms
mesh term: Xerostomia
sharing ipd: No