<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/NCT01697891</url>
  </required_header>
  <id_info>
    <org_study_id>MU12-530</org_study_id>
    <nct_id>NCT01697891</nct_id>
  </id_info>
  <brief_title>A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers</brief_title>
  <official_title>Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagia and Associated Symptoms of Chemotherapy and/or Intensity Modulated Radiation Therapy (IMRT) for Head and Neck Cancers: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation&#xD;
      completion, can improve radiation-induced dysphagia and associated symptoms in head and neck&#xD;
      cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory&#xD;
      response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.&#xD;
&#xD;
      Primary study objective: To evaluate the effectiveness of ALTENS in relieving&#xD;
      radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this&#xD;
      primary study endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Difficulty in swallowing is a concerning symptom after radiation treatment for some types of&#xD;
      head and neck cancers. Swallowing becomes difficult when radiation damage induces&#xD;
      inflammation (with swelling and pain) in the inner covering tissues of the throat and muscles&#xD;
      that involve in the swallowing process. Currently, supportive measures are used to manage&#xD;
      this symptom while waiting for the tissue damages to heal. In some patients, the inflamed&#xD;
      muscles develop scar tissues causing long-term swallowing difficulty and narrowing of the&#xD;
      swallowing passage. Needle acupuncture may help to reduce tissue inflammation and may lessen&#xD;
      the severity of swallowing difficulty. However, needle puncture is often not desired by&#xD;
      patients. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is like&#xD;
      acupuncture treatment, but the acupuncture points are stimulated with mild electrical&#xD;
      stimulation without needles, simplifying treatment delivery. This study is to examine if a&#xD;
      pre-selected set of acupuncture points treated using ALTENS can reduce swallowing difficulty.&#xD;
      There will be a total of 12 treatments given over 6 to 8 weeks. Changes in severity of&#xD;
      swallowing difficult after treatment will be assessed using 2 subjective assessment tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline</measure>
    <time_frame>3 months after treatment completion</time_frame>
    <description>EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in M. D. Anderson dysphagia inventory from baseline</measure>
    <time_frame>3 months after treatment completion</time_frame>
    <description>M. D. Anderson dysphagia inventory (MDADI) is a self-administered questionnaire designed specifically to assess the quality of life for head and neck cancer patients who suffer from dysphagia. It incorporated three domains: emotional, functional and physical, and one global question. There are a total of 20 items.Each item is scored on a scale of 1 to 5 with 1 being strongly agree and 5 strongly disagree except for two items, one on the emotional subscale and the other on the functional subscale. The global question is scored and interpreted separately. The scores of all the items in each domain are summed and a mean score is calculated. The final score for each subscale is calculated by multiplying the calculated mean score by 20 with a final range from 0 to 100. The final score of the global question is also calculated in the same way. The higher the final score represents better functioning and quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>ALTENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Codetron ALTENS</intervention_name>
    <description>ALTENS stimulation of a set of selected acupuncture points for 20 minutes in each treatment. Two treatments per week for a total of 12 treatments to be delivered within 8 weeks.</description>
    <arm_group_label>ALTENS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:This study will recruit patients with head and neck cancers treated with&#xD;
        radiation+/- chemotherapy and who meet the following criteria (EAT-10 assessment will be&#xD;
        used for screening):&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          1. present with dysphagia symptoms&#xD;
&#xD;
          2. with no evidence of residue cancer&#xD;
&#xD;
          3. are within 3 months (but past 1 month) after treatment completion&#xD;
&#xD;
          4. show positive dysphagia (EAT-10 score of &gt; 3) and/ or aspiration on barium swallow&#xD;
             study&#xD;
&#xD;
          5. are over 18 years old&#xD;
&#xD;
          6. are able to read and write fluent English&#xD;
&#xD;
          7. can give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. have unstable heart disease&#xD;
&#xD;
          2. have infectious disease transmissible by blood or body fluid, including hepatitis and&#xD;
             HIV&#xD;
&#xD;
          3. have skin disease at site of study acupuncture points that prevents the application of&#xD;
             electrodes&#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>Raimond Wong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Raimond Wong</investigator_full_name>
    <investigator_title>Associate Professor, Department of Oncology</investigator_title>
  </responsible_party>
  <keyword>Radiation Treatment</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Dysphagia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Deglutition Disorders</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/NCT01697891
org study id: MU12-530
nct id: NCT01697891
lead sponsor: 
collaborator: 
has dmc: No
Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation
      completion, can improve radiation-induced dysphagia and associated symptoms in head and neck
      cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory
      response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis.

      Primary study objective: To evaluate the effectiveness of ALTENS in relieving
      radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this
      primary study endpoint.
Difficulty in swallowing is a concerning symptom after radiation treatment for some types of
      head and neck cancers. Swallowing becomes difficult when radiation damage induces
      inflammation (with swelling and pain) in the inner covering tissues of the throat and muscles
      that involve in the swallowing process. Currently, supportive measures are used to manage
      this symptom while waiting for the tissue damages to heal. In some patients, the inflamed
      muscles develop scar tissues causing long-term swallowing difficulty and narrowing of the
      swallowing passage. Needle acupuncture may help to reduce tissue inflammation and may lessen
      the severity of swallowing difficulty. However, needle puncture is often not desired by
      patients. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is like
      acupuncture treatment, but the acupuncture points are stimulated with mild electrical
      stimulation without needles, simplifying treatment delivery. This study is to examine if a
      pre-selected set of acupuncture points treated using ALTENS can reduce swallowing difficulty.
      There will be a total of 12 treatments given over 6 to 8 weeks. Changes in severity of
      swallowing difficult after treatment will be assessed using 2 subjective assessment tools.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
time frame: 3 months after treatment completion
description: EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.
measure: Change in M. D. Anderson dysphagia inventory from baseline
time frame: 3 months after treatment completion
description: M. D. Anderson dysphagia inventory (MDADI) is a self-administered questionnaire designed specifically to assess the quality of life for head and neck cancer patients who suffer from dysphagia. It incorporated three domains: emotional, functional and physical, and one global question. There are a total of 20 items.Each item is scored on a scale of 1 to 5 with 1 being strongly agree and 5 strongly disagree except for two items, one on the emotional subscale and the other on the functional subscale. The global question is scored and interpreted separately. The scores of all the items in each domain are summed and a mean score is calculated. The final score for each subscale is calculated by multiplying the calculated mean score by 20 with a final range from 0 to 100. The final score of the global question is also calculated in the same way. The higher the final score represents better functioning and quality of life.
arm group label: ALTENS
arm group type: Experimental
description: Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)
intervention type: Device
intervention name: Codetron ALTENS
description: ALTENS stimulation of a set of selected acupuncture points for 20 minutes in each treatment. Two treatments per week for a total of 12 treatments to be delivered within 8 weeks.
arm group label: ALTENS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raimond Wong, MD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Raimond Wong
investigator title: Associate Professor, Department of Oncology
mesh term: Head and Neck Neoplasms
mesh term: Deglutition Disorders