<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/NCT03035825</url>
  </required_header>
  <id_info>
    <org_study_id>DIF-05</org_study_id>
    <nct_id>NCT03035825</nct_id>
  </id_info>
  <brief_title>Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients</brief_title>
  <official_title>A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dental Innovation Foundation Under Royal Patronage</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Srinakharinwirot University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dental Innovation Foundation Under Royal Patronage</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 randomized control trial aims to investigate the efficacy of oral moisturizing jelly in&#xD;
      head and neck cancer patients with xerostomia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven&#xD;
      effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This&#xD;
      randomized control trial intends to determine if continuous use of oral moisturizing jelly&#xD;
      may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical&#xD;
      properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy&#xD;
      intake and reduce umami taste recognition threshold.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in subjective dry mouth score compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of subjective dry mouth score by questionaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in objective dry mouth score compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of objective dry mouth score by oral examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in salivary pH compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of salivary pH using pH indicator paper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in salivary buffering capacity compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of salivary buffering capacity using a commercial saliva check buffer kit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Candidal counts of saliva compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of number of fungal colonies of Candida spp. in saliva by culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in energy intake compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of energy intake per day using dietary record and analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in subjective swallow ability compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of subjective swallow ability using EAT-10 questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in appetite compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of appetite using questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tolerance to spicy food</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of tolerance to spicy food using questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in umami taste recognition threshold compared to baseline</measure>
    <time_frame>Baseline, 1 and 2 months after intervention</time_frame>
    <description>Evaluation of umami taste recognition threshold using filter paper disc method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Cancer of Head Neck</condition>
  <condition>Radiation-Induced Xerostomia</condition>
  <condition>Dry Mouth</condition>
  <arm_group>
    <arm_group_label>Oral Moisturizing Jelly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily intake of oral moisturizing jelly 5 times/day for two months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artificial saliva</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily use of non-edible oral lubricating gel 5 times/day for two months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral moisturizing jelly</intervention_name>
    <description>Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth</description>
    <arm_group_label>Oral Moisturizing Jelly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Artificial saliva</intervention_name>
    <description>A non-edible oral lubricating gel for dry mouth patients</description>
    <arm_group_label>Artificial saliva</arm_group_label>
    <other_name>Dry mouth gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.&#xD;
&#xD;
          2. If undergoing chemotherapy, have to finish for at least 2 weeks.&#xD;
&#xD;
          3. Have subjective dry mouth scores at least 3&#xD;
&#xD;
          4. Can perform oral intake without aspiration&#xD;
&#xD;
          5. Can communicate well&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has recurrence of cancer&#xD;
&#xD;
          2. Has mucositis more than grade 1&#xD;
&#xD;
          3. Has oral infection such as candidiasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aroonwan Lam-ubol, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Srinakarinwirot University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chonburi Cancer Hospital</name>
      <address>
        <city>Chonburi</city>
        <zip>20000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT03035825
org study id: DIF-05
nct id: NCT03035825
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in
      head and neck cancer patients with xerostomia.
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven
      effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This
      randomized control trial intends to determine if continuous use of oral moisturizing jelly
      may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical
      properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy
      intake and reduce umami taste recognition threshold.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Changes in subjective dry mouth score compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of subjective dry mouth score by questionaire
measure: Changes in objective dry mouth score compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of objective dry mouth score by oral examination
measure: Changes in salivary pH compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of salivary pH using pH indicator paper
measure: Changes in salivary buffering capacity compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of salivary buffering capacity using a commercial saliva check buffer kit
measure: Changes in Candidal counts of saliva compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of number of fungal colonies of Candida spp. in saliva by culture
measure: Changes in energy intake compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of energy intake per day using dietary record and analysis
measure: Changes in subjective swallow ability compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of subjective swallow ability using EAT-10 questionaire
measure: Changes in appetite compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of appetite using questionnaire
measure: Changes in tolerance to spicy food
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of tolerance to spicy food using questionnaire
measure: Changes in umami taste recognition threshold compared to baseline
time frame: Baseline, 1 and 2 months after intervention
description: Evaluation of umami taste recognition threshold using filter paper disc method
arm group label: Oral Moisturizing Jelly
arm group type: Experimental
description: Daily intake of oral moisturizing jelly 5 times/day for two months
arm group label: Artificial saliva
arm group type: Active Comparator
description: Daily use of non-edible oral lubricating gel 5 times/day for two months
intervention type: Dietary Supplement
intervention name: Oral moisturizing jelly
description: Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
arm group label: Oral Moisturizing Jelly
intervention type: Other
intervention name: Artificial saliva
description: A non-edible oral lubricating gel for dry mouth patients
arm group label: Artificial saliva
other name: Dry mouth gel
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Aroonwan Lam-ubol, DDS, PhD
role: Principal Investigator
affiliation: Srinakarinwirot University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Xerostomia
sharing ipd: No