<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/NCT02198131</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00011092</org_study_id>
    <secondary_id>NCI-2014-01458</secondary_id>
    <secondary_id>CCCWFU 98214</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT02198131</nct_id>
  </id_info>
  <brief_title>Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia</brief_title>
  <official_title>Pulsed Dye Laser for Treatment of Post Radiation Dysphonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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 pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia.&#xD;
      Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk,&#xD;
      such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens&#xD;
      after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation&#xD;
      dysphonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly&#xD;
      results after radiation therapy for laryngeal carcinoma.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo pulsed dye laser monthly for three months.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1, 3, and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</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>Videostroboscopy rates</measure>
    <time_frame>Up to 6 months post-treatment</time_frame>
    <description>Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Voice Handicap Index (VHI)-10 score</measure>
    <time_frame>Baseline to 6 months post-treatment</time_frame>
    <description>The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in jitter</measure>
    <time_frame>Baseline and at 6 months post-treatment</time_frame>
    <description>Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voice quality using the patient self-assessment questionnaire</measure>
    <time_frame>Up to 6 months post-treatment</time_frame>
    <description>The post treatment questionnaire form will be scored and then comparisons made for each individual question on the form across our study group. These values will be discrete variables.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in shimmer</measure>
    <time_frame>Baseline and at 6 months post-treatment</time_frame>
    <description>Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in noise to harmonic ratio</measure>
    <time_frame>Baseline and at 6 months post-treatment</time_frame>
    <description>Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean phonatory flow</measure>
    <time_frame>Baseline and at 6 months post-treatment</time_frame>
    <description>Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Oral Complications of Radiation Therapy</condition>
  <condition>Stage I Laryngeal Cancer</condition>
  <condition>Stage II Laryngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Supportive Care (pulsed dye laser)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo pulsed dye laser monthly for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laser therapy</intervention_name>
    <description>Undergo pulsed dye laser</description>
    <arm_group_label>Supportive Care (pulsed dye laser)</arm_group_label>
    <other_name>therapy, laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (pulsed dye laser)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from dysphonia after radiation therapy for glottic carcinoma will&#xD;
             be included in the study&#xD;
&#xD;
          -  Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having previously undergone large surgical resections of the larynx or&#xD;
             hypopharynx will be excluded&#xD;
&#xD;
          -  Patients fewer than 1 year out from completion of radiation therapy will be excluded&#xD;
&#xD;
          -  Patients with local disease recurrence would be excluded from the trial&#xD;
&#xD;
          -  Patients in whom the transnasal endoscope is poorly tolerated or patients in whom&#xD;
             transnasal endoscopic laryngoscopy is contraindicated will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carter Wright</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</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>Laryngeal Neoplasms</mesh_term>
    <mesh_term>Dysphonia</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/NCT02198131
org study id: IRB00011092
secondary id: NCI-2014-01458
secondary id: CCCWFU 98214
secondary id: P30CA012197
nct id: NCT02198131
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia.
      Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk,
      such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens
      after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation
      dysphonia.
PRIMARY OBJECTIVES:

      I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly
      results after radiation therapy for laryngeal carcinoma.

      OUTLINE:

      Patients undergo pulsed dye laser monthly for three months.

      After completion of study treatment, patients are followed up at 1, 3, and 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Videostroboscopy rates
time frame: Up to 6 months post-treatment
description: Forced choice comparisons will be utilized in the pre and post treatment stroboscopy comparisons.
measure: Change in Voice Handicap Index (VHI)-10 score
time frame: Baseline to 6 months post-treatment
description: The VHI-10 form will be scored and then those numbers will be compared pre and post treatment for each individual.
measure: Change in jitter
time frame: Baseline and at 6 months post-treatment
description: Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
measure: Voice quality using the patient self-assessment questionnaire
time frame: Up to 6 months post-treatment
description: The post treatment questionnaire form will be scored and then comparisons made for each individual question on the form across our study group. These values will be discrete variables.
measure: Change in shimmer
time frame: Baseline and at 6 months post-treatment
description: Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
measure: Change in noise to harmonic ratio
time frame: Baseline and at 6 months post-treatment
description: Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
measure: Change in mean phonatory flow
time frame: Baseline and at 6 months post-treatment
description: Laboratory based voice analysis will be performed with evaluations of aerodynamics and acoustics.
arm group label: Supportive Care (pulsed dye laser)
arm group type: Experimental
description: Patients undergo pulsed dye laser monthly for three months.
intervention type: Procedure
intervention name: laser therapy
description: Undergo pulsed dye laser
arm group label: Supportive Care (pulsed dye laser)
other name: therapy, laser
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Supportive Care (pulsed dye laser)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Carter Wright
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Laryngeal Neoplasms
mesh term: Dysphonia