<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/NCT01693159</url>
  </required_header>
  <id_info>
    <org_study_id>Uni-HD-2010-33-40-1003</org_study_id>
    <nct_id>NCT01693159</nct_id>
  </id_info>
  <brief_title>Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades</brief_title>
  <acronym>SUPPORT</acronym>
  <official_title>Randomized Controlled Multicenter Trial to Evaluate the Effects of Ethyl-2-cyanoacrylate on Pain Intensity and Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades During Radioimmunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for Tumor Diseases, Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>iOMEDICO AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Center for Tumor Diseases, Heidelberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SUPPORT trial is an open-label, prospective, randomized, national multicenter&#xD;
      intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard&#xD;
      treatment of each institution on the pain intensity and QoL in patients with locally advanced&#xD;
      head and neck cancer suffering from painful cetuximab-induced rhagades during&#xD;
      radioimmunotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2011</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)</measure>
    <time_frame>24 hours after application</time_frame>
    <description>pain intensity quantified by the visual analogue scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of QoL</measure>
    <time_frame>5 to 7 days after application of treatment</time_frame>
    <description>Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>SUPO-Score for classification of cetuximab-induced rhagades</measure>
    <time_frame>24 hours and 5 to 7 days after application of treatment</time_frame>
    <description>SUPO-Score for classification of cetuximab-induced rhagades:&#xD;
Grade 1: Rhagades without clinical symptoms&#xD;
Grade 2: Painful rhagades Grade 2a: Moderate pain, no impairment of activity in the daily routine (ADL) Grade 2b: Severe pain and impairment of the activities of daily living (ADL) Grade 3: Painful, deep and spontaneously bleeding rhagades&#xD;
Grade 4: Superinfection of the rhagades (detection of bacterial growth) Grade 4a: Local infection Grade 4b: Systemic infection&#xD;
Grade 5: Death due to complications of the rhagades</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events of ECA</measure>
    <time_frame>from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment</time_frame>
    <description>Adverse Events of ECA due to NCI CTCAE v. 4.02</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>ECA: Ethyl-2-cyanoacrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment of the institution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment of the institution to treat painful cetuximab-induced rhagades</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECA</intervention_name>
    <description>In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).</description>
    <arm_group_label>ECA: Ethyl-2-cyanoacrate</arm_group_label>
    <other_name>Ethyl-2-cyanoacrylate (ECA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard topical treatment of the institution, e.g. Lotio</intervention_name>
    <description>Standard treatment of the institution to treat painful cetuximab-induced rhagades</description>
    <arm_group_label>Standard treatment of the institution</arm_group_label>
    <other_name>Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced squamous cell carcinoma of the head and neck and participation in the&#xD;
             HICARE-phase-IV-trial&#xD;
&#xD;
          -  Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)&#xD;
&#xD;
          -  Compliance to the photo documentation&#xD;
&#xD;
          -  Ability of subject to understand character and individual consequences of the clinical&#xD;
             trial&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1&#xD;
&#xD;
          -  Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades&#xD;
&#xD;
          -  Patients not being enrolled in the HICARE trial&#xD;
&#xD;
          -  Substance misuse, psychoactive substance abuse or psychological/social conditions&#xD;
             leading to a decreased patients' compliance with possible bad influence to the results&#xD;
             of the study&#xD;
&#xD;
          -  Known allergic reaction to ethyl-2-cyanoacrylate (ECA)&#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>Karin Potthoff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Tumor Diseases, Heidelberg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karin Potthoff, Dr.</last_name>
    <phone>+496221568201</phone>
    <email>karin.potthoff@med.uni-heidelberg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Indorf, Dr.</last_name>
    <phone>+497611524257</phone>
    <email>martin.indorf@iomedico.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Heidelberg Medical Center</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karin Potthoff, MD</last_name>
      <phone>+496221568201</phone>
      <email>karin.potthoff@med.uni-heidelberg.de</email>
    </contact>
    <contact_backup>
      <last_name>Matthias Haefner, MD</last_name>
      <phone>+496221568201</phone>
      <email>matthias.haefner@med.uni-heidelberg.de</email>
    </contact_backup>
    <investigator>
      <last_name>Karin Potthoff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthias Haefner, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juergen Debus, Prof. Dr. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Painful cetuximab-induced rhagades</keyword>
  <keyword>Radioimmunotherapy</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethyl 2-cyanoacrylate</mesh_term>
  </intervention_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/NCT01693159
org study id: Uni-HD-2010-33-40-1003
nct id: NCT01693159
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The SUPPORT trial is an open-label, prospective, randomized, national multicenter
      intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard
      treatment of each institution on the pain intensity and QoL in patients with locally advanced
      head and neck cancer suffering from painful cetuximab-induced rhagades during
      radioimmunotherapy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
time frame: 24 hours after application
description: pain intensity quantified by the visual analogue scale (VAS)
measure: Evaluation of QoL
time frame: 5 to 7 days after application of treatment
description: Evaluation of QoL assessed by the EORTC-QoL-C30 questionnaire and the Dermatological Life Quality Index (DLQI)
measure: SUPO-Score for classification of cetuximab-induced rhagades
time frame: 24 hours and 5 to 7 days after application of treatment
description: SUPO-Score for classification of cetuximab-induced rhagades:
Grade 1: Rhagades without clinical symptoms
Grade 2: Painful rhagades Grade 2a: Moderate pain, no impairment of activity in the daily routine (ADL) Grade 2b: Severe pain and impairment of the activities of daily living (ADL) Grade 3: Painful, deep and spontaneously bleeding rhagades
Grade 4: Superinfection of the rhagades (detection of bacterial growth) Grade 4a: Local infection Grade 4b: Systemic infection
Grade 5: Death due to complications of the rhagades
measure: Adverse Events of ECA
time frame: from time of randomization untio end of study, i.e. until 5 to 7 days after application of treatment
description: Adverse Events of ECA due to NCI CTCAE v. 4.02
arm group label: ECA: Ethyl-2-cyanoacrate
arm group type: Experimental
description: Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
arm group label: Standard treatment of the institution
arm group type: Active Comparator
description: Standard treatment of the institution to treat painful cetuximab-induced rhagades
intervention type: Device
intervention name: ECA
description: In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
arm group label: ECA: Ethyl-2-cyanoacrate
other name: Ethyl-2-cyanoacrylate (ECA)
intervention type: Other
intervention name: Standard topical treatment of the institution, e.g. Lotio
description: Standard treatment of the institution to treat painful cetuximab-induced rhagades
arm group label: Standard treatment of the institution
other name: Ointment, Creme, Lotio, for example dexpanthenol-containing topical treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karin Potthoff, MD
role: Principal Investigator
affiliation: National Center for Tumor Diseases, Heidelberg
last name: Karin Potthoff, Dr.
phone: +496221568201
email: karin.potthoff@med.uni-heidelberg.de
last name: Martin Indorf, Dr.
phone: +497611524257
email: martin.indorf@iomedico.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Ethyl 2-cyanoacrylate