<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/NCT01733797</url>
  </required_header>
  <id_info>
    <org_study_id>09DOG0843</org_study_id>
    <secondary_id>ISRCTN79084153</secondary_id>
    <secondary_id>PB-PG-0610-22317</secondary_id>
    <nct_id>NCT01733797</nct_id>
  </id_info>
  <brief_title>Trismus Trial of Therabite vs Wooden Spatula in Head and Neck Cancer Patients</brief_title>
  <official_title>Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brynn Chappell</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Christie NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Christie NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial will compare exercises using Therabite® versus wooden spatulas to prevent or&#xD;
      relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the&#xD;
      quality of life of head and neck cancer patients is well established. It affects eating,&#xD;
      drinking, speaking and social function and is often as debilitating as any disfigurement&#xD;
      resulting from treatment.&#xD;
&#xD;
      The use of jaw exercises using a Therabite appliance following treatment has been shown to&#xD;
      reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden&#xD;
      spatulas inserted between the incisors as a means of passive exercise. There is anecdotal&#xD;
      evidence that suggests the use of exercises prior to treatment may help reduce the severity&#xD;
      of the Trismus experienced by the patient.&#xD;
&#xD;
      This study will enrol 112 head and neck cancer patients allocated by chance to use either the&#xD;
      Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily&#xD;
      basis for 6 months.&#xD;
&#xD;
      There is a need to evaluate both the clinical effectiveness and cost-effectiveness of&#xD;
      Therabite as opposed to wooden spatulas to determine whether they should be adopted as&#xD;
      standard care in head and neck cancer patients.&#xD;
&#xD;
      In this pilot trial, the investigators will measure benefits of Therabite to patients, as&#xD;
      compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Jaw measurement</measure>
    <time_frame>Baseline, 3 months and 6 months at hopsital</time_frame>
    <description>Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to intervention</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Adherence to device use will be captured by the patient on a progress log</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Patients hospital and service use will be captured at Baseline, 3 and 6 months during interviews with the patient.&#xD;
Units used will be days in hospital or number of appointments</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <condition>Oral Cancer</condition>
  <arm_group>
    <arm_group_label>Wooden spatula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Therabite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wooden spatula</intervention_name>
    <description>Lollipop sticks placed between incisors</description>
    <arm_group_label>Wooden spatula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Therabite</intervention_name>
    <description>Hand held device placed in mouth that exercises the jaw</description>
    <arm_group_label>Therabite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of signed, written informed consent&#xD;
&#xD;
          -  Aged 18 years and older&#xD;
&#xD;
          -  Able to read and write English sufficiently to be able to complete questionnaires&#xD;
&#xD;
          -  Stage 3/4 oral and oropharyngeal cancer patients undergoing:&#xD;
&#xD;
        Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post&#xD;
        operative chemoradiotherapy&#xD;
&#xD;
          -  All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region&#xD;
             of the pterygoid muscles.&#xD;
&#xD;
          -  All patients will have at least some trismus as indicated by subjective tightening in&#xD;
             the jaw.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;12mm mouth opening (cannot use Therabite)&#xD;
&#xD;
          -  Anatomically unable to use Therabite for example patients who may only be partially&#xD;
             dentate and to use the Therabite would place extreme stress on the existing teeth&#xD;
&#xD;
          -  Cognitive impairment as judged by the clinicians&#xD;
&#xD;
          -  International patients treated who will not have routine UK follow up.&#xD;
&#xD;
          -  Previous surgery or RT to the head and neck prior to this diagnosis&#xD;
&#xD;
          -  Any patient who has no subjective tightening of the jaw.&#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>Prof Slevin</last_name>
    <role>Study Chair</role>
    <affiliation>The Christie NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Victoria Hospital</name>
      <address>
        <city>East Grinstead</city>
        <zip>RH19 3DZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.christie.nhs.uk/</url>
    <description>Christie NHS website</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Christie NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Brynn Chappell</investigator_full_name>
    <investigator_title>Clinical Trials Project Manager</investigator_title>
  </responsible_party>
  <keyword>Trismus</keyword>
  <keyword>Therabite</keyword>
  <keyword>Wooden spatula</keyword>
  <keyword>Head and Neck cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Mouth Neoplasms</mesh_term>
    <mesh_term>Trismus</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/NCT01733797
org study id: 09DOG0843
secondary id: ISRCTN79084153
secondary id: PB-PG-0610-22317
nct id: NCT01733797
lead sponsor: 
collaborator: 
has dmc: No
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or
      relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.
Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the
      quality of life of head and neck cancer patients is well established. It affects eating,
      drinking, speaking and social function and is often as debilitating as any disfigurement
      resulting from treatment.

      The use of jaw exercises using a Therabite appliance following treatment has been shown to
      reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden
      spatulas inserted between the incisors as a means of passive exercise. There is anecdotal
      evidence that suggests the use of exercises prior to treatment may help reduce the severity
      of the Trismus experienced by the patient.

      This study will enrol 112 head and neck cancer patients allocated by chance to use either the
      Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily
      basis for 6 months.

      There is a need to evaluate both the clinical effectiveness and cost-effectiveness of
      Therabite as opposed to wooden spatulas to determine whether they should be adopted as
      standard care in head and neck cancer patients.

      In this pilot trial, the investigators will measure benefits of Therabite to patients, as
      compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Jaw measurement
time frame: Baseline, 3 months and 6 months at hopsital
description: Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
measure: Adherence to intervention
time frame: up to 6 months
description: Adherence to device use will be captured by the patient on a progress log
measure: Quality of Life
time frame: Baseline, 3 and 6 months
measure: Health economic analysis
time frame: Baseline, 3 and 6 months
description: Patients hospital and service use will be captured at Baseline, 3 and 6 months during interviews with the patient.
Units used will be days in hospital or number of appointments
arm group label: Wooden spatula
arm group type: Experimental
arm group label: Therabite
arm group type: Experimental
intervention type: Device
intervention name: Wooden spatula
description: Lollipop sticks placed between incisors
arm group label: Wooden spatula
intervention type: Device
intervention name: Therabite
description: Hand held device placed in mouth that exercises the jaw
arm group label: Therabite
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prof Slevin
role: Study Chair
affiliation: The Christie NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
url: http://www.christie.nhs.uk/
description: Christie NHS website
responsible party type: Sponsor-Investigator
investigator affiliation: The Christie NHS Foundation Trust
investigator full name: Brynn Chappell
investigator title: Clinical Trials Project Manager
mesh term: Head and Neck Neoplasms
mesh term: Oropharyngeal Neoplasms
mesh term: Mouth Neoplasms
mesh term: Trismus