<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/NCT02243722</url>
  </required_header>
  <id_info>
    <org_study_id>102-5333A3</org_study_id>
    <nct_id>NCT02243722</nct_id>
  </id_info>
  <brief_title>Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment</brief_title>
  <official_title>Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance,&#xD;
      which often happens after the treatment for laryngopharyngeal and esophageal cancer and may&#xD;
      induce fatal complications such as aspiration pneumonia. By the conventional examinations,&#xD;
      the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It&#xD;
      is utmost important to establish a comprehensive quantitative method which is sensitive&#xD;
      enough to evaluate the neuromuscular functions. The present project will evaluate the&#xD;
      laryngeal nerve function by quantitative laryngeal electromyography, which was developed by&#xD;
      the research team, and another novel examination technique, mucosal membrane sensation test.&#xD;
      The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively&#xD;
      before the significant symptoms or complications and can also help to evaluate the treatment&#xD;
      effect from medicine, rehabilitation or surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Fiberoptic endoscopic evaluation of swallowing (FEES)</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>Swallowing evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laryngo-pharyngeal mucosa sensation test</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>There were four probes of different diameters that similar to the Von Frey filament were prepared for the examination. The diameters were 0.07mm, 0.15mm.0.2 mm and 0.3 mm. The mono-filament nylon probe was placed and contact with the tip and arytenoid mucosa.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>laryngeal electromyography</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>laboratory voice analysis</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>voice range profile</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>The voice will be analyzed by computerized software. The extreme lowest and highest notes of frequencies production and the amplitude will be recorded and a voice map will be made as a plot of sound pressure level versus F0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Voice Handicap Index (VHI)</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>Voice-related questionnaire The Voice Handicap Index (VHI) is a 30-item instrument developed by Jacobson et al. as a self-measure the psychosocial handicapping effects of voice disorders. The questionnaire consists of three sub scales: emotional, physical and functional with 10 items from each scale. It has been translated into traditional Chinese and validated. All individuals will be asked to response for the questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease related life quality assessment: FACT-H&amp;N, FACT-E</measure>
    <time_frame>Baseline:Within 3-6 months after synptom occurs</time_frame>
    <description>Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&amp;N) and FACT-E (esophagus) are self -report questionnaires with a Likert-type response set, ranging from &quot;not at all&quot; to &quot;very much&quot;. FACT-G (general) is a 27-items scale measures four QOL (quality of life) domains including Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. In FACT-H&amp;N, there are 11 additional specific questions for head and neck cancers while 17 additional items for esophageal cancers in FACT-E. The specific questionnaires will be provided to patients according to individual diseases. The traditional Chinese (Mandarin) version has been validated and proved to be useful in previous report. We have received the licensing agreement from the institute (FACIT) for using the questionnaires on the project.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Unilateral Vocal Cord Paralysis</condition>
  <arm_group>
    <arm_group_label>Larynx pharynx and Esophagus Ca with VCP</arm_group_label>
    <description>The cases of laryngopharyngeal and esophageal cancer with endoscopic characters of vocal fold motion impairment (paralysis or fixation)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from a tertian referral medical center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with laryngopharyngeal or esophageal cancer who have taken active therapy and&#xD;
             are not neck tissue damage.&#xD;
&#xD;
          -  Patients with clear conscious and stable mental status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot sit for longer than 30 minutes or received other vocal cord&#xD;
             treatments before the selection&#xD;
&#xD;
          -  Pregnant and breastfeeding women&#xD;
&#xD;
          -  Patients with communication disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuan-Jen Fang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tuan-Jen Fang, MD</last_name>
    <email>fang3109@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laryngeal electromyography</keyword>
  <keyword>intrinsic laryngeal muscles</keyword>
  <keyword>recurrent laryngeal nerve</keyword>
  <keyword>superior laryngeal nerve</keyword>
  <keyword>laryngeal sensation</keyword>
  <keyword>tone language</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</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/NCT02243722
org study id: 102-5333A3
nct id: NCT02243722
lead sponsor: 
has dmc: Yes
Laryngeal motor and sensory nerve dysfunction may cause phonation and swallowing disturbance,
      which often happens after the treatment for laryngopharyngeal and esophageal cancer and may
      induce fatal complications such as aspiration pneumonia. By the conventional examinations,
      the tiny sensory or motor changes are hard to be detected before complete vocal paralysis. It
      is utmost important to establish a comprehensive quantitative method which is sensitive
      enough to evaluate the neuromuscular functions. The present project will evaluate the
      laryngeal nerve function by quantitative laryngeal electromyography, which was developed by
      the research team, and another novel examination technique, mucosal membrane sensation test.
      The comprehensive method is expected to grade the laryngeal nerve injuries quantitatively
      before the significant symptoms or complications and can also help to evaluate the treatment
      effect from medicine, rehabilitation or surgery.
observational model: Cohort
time perspective: Cross-Sectional
measure: Fiberoptic endoscopic evaluation of swallowing (FEES)
time frame: Baseline:Within 3-6 months after synptom occurs
description: Swallowing evaluation
measure: Laryngo-pharyngeal mucosa sensation test
time frame: Baseline:Within 3-6 months after synptom occurs
description: There were four probes of different diameters that similar to the Von Frey filament were prepared for the examination. The diameters were 0.07mm, 0.15mm.0.2 mm and 0.3 mm. The mono-filament nylon probe was placed and contact with the tip and arytenoid mucosa.
measure: laryngeal electromyography
time frame: Baseline:Within 3-6 months after synptom occurs
measure: laboratory voice analysis
time frame: Baseline:Within 3-6 months after synptom occurs
description: fundamental frequency, Jitter (perturbation of frequency), Shimmer (perturbation of amplitude), harmonic-to-noise ratio (HN), and s/z ratio (SZ) .
measure: voice range profile
time frame: Baseline:Within 3-6 months after synptom occurs
description: The voice will be analyzed by computerized software. The extreme lowest and highest notes of frequencies production and the amplitude will be recorded and a voice map will be made as a plot of sound pressure level versus F0.
measure: Voice Handicap Index (VHI)
time frame: Baseline:Within 3-6 months after synptom occurs
description: Voice-related questionnaire The Voice Handicap Index (VHI) is a 30-item instrument developed by Jacobson et al. as a self-measure the psychosocial handicapping effects of voice disorders. The questionnaire consists of three sub scales: emotional, physical and functional with 10 items from each scale. It has been translated into traditional Chinese and validated. All individuals will be asked to response for the questionnaire.
measure: Disease related life quality assessment: FACT-H&N, FACT-E
time frame: Baseline:Within 3-6 months after synptom occurs
description: Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) and FACT-E (esophagus) are self -report questionnaires with a Likert-type response set, ranging from "not at all" to "very much". FACT-G (general) is a 27-items scale measures four QOL (quality of life) domains including Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. In FACT-H&N, there are 11 additional specific questions for head and neck cancers while 17 additional items for esophageal cancers in FACT-E. The specific questionnaires will be provided to patients according to individual diseases. The traditional Chinese (Mandarin) version has been validated and proved to be useful in previous report. We have received the licensing agreement from the institute (FACIT) for using the questionnaires on the project.
arm group label: Larynx pharynx and Esophagus Ca with VCP
description: The cases of laryngopharyngeal and esophageal cancer with endoscopic characters of vocal fold motion impairment (paralysis or fixation)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Tuan-Jen Fang, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Tuan-Jen Fang, MD
email: fang3109@cgmh.org.tw
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Vocal Cord Paralysis
mesh term: Paralysis