<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/NCT01670786</url>
  </required_header>
  <id_info>
    <org_study_id>GPPOT-02</org_study_id>
    <nct_id>NCT01670786</nct_id>
  </id_info>
  <brief_title>Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion</brief_title>
  <official_title>Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Pesquisa em Pleura e Oncologia Toracica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto do Coracao</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo de Pesquisa em Pleura e Oncologia Toracica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural&#xD;
      effusion, with minimal adverse events, especially reducing dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Chemical pleurodesis is the treatment of choice in most cases of malignant&#xD;
      pleural effusion. The literature mentions a variety of chemicals which may be used for this&#xD;
      purpose, each with its own advantages and disadvantages. The iodopovidone has been recently&#xD;
      studied due to the existence of some side effects of other agents. Nevertheless, there are&#xD;
      still some questions in the literature regarding its safety and possible adverse effects.&#xD;
      Because of these questions, we propose the development of a study to ensure the safety and&#xD;
      efficacy of iodopovidone as a pleurodesis sclerosing agent.&#xD;
&#xD;
      Objective: The main purpose of this study is to evaluate the safety of pleurodesis for&#xD;
      malignant pleural effusion using iodopovidone as a sclerosing agent in different doses. The&#xD;
      secondary objectives are to determine clinical efficacy and quality of life of the patients&#xD;
      after realization of the proposed procedure.&#xD;
&#xD;
      Methods: There will be a randomized clinical trial, covering patients diagnosed with&#xD;
      malignant pleural effusion at Hospital Aristides Maltez - Bahia League Against Cancer. The&#xD;
      research was revised and approved by the Ethics in Research of the Heart Institute, Hospital&#xD;
      das Clínicas - FMUSP and of the Hospital Aristides Maltez - Bahia League Against Cancer. The&#xD;
      free and informed consent was evaluated by the same authority pursuant and the study group&#xD;
      included only those who agree to participate and signed an approved. There included patients&#xD;
      with malignant pleural effusion diagnosis. Main exclusion criteria were iodine allergia,&#xD;
      renal failure, thyroid disease, refusal to sign the informed consent and patients unable to&#xD;
      respond the quality of life questionnaire. After inclusion, patients were randomized and&#xD;
      assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All&#xD;
      procedures were performed by infusion of the solution through a chest tube previously&#xD;
      placed.The data analysis involved clinical measures and complementary exams trying to&#xD;
      evaluate all organ systems and sorting through possible adverse effects, classifying those as&#xD;
      CTCAEV. Clinical measures involved MRC dyspnea schedule, analogic visual pain schedule,&#xD;
      visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and&#xD;
      temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.&#xD;
      Such measures were performed in the preoperative, immediate postoperative, second, fourth,&#xD;
      eleventh and thirty days postoperative. Quality of life questionnaires was applied before and&#xD;
      on thirty days postoperative as well. After that, randomized groups were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of iodopovidone as an agent for pleurodesis</measure>
    <time_frame>Until 30th day after surgical procedure</time_frame>
    <description>The safety was assessed by mean clinical measures as MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Until 1 week before the procedure date and 1 month after it</time_frame>
    <description>Quality of life questionnaires were applied until 1 week before the procedure date and on thirty days postoperative as well.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Efficacy of iodopovidone as an agent for pleurodesis</measure>
    <time_frame>Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure</time_frame>
    <description>The efficacy assessment was based on need of additional pleural surgical procedures.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pleural Effusion, Malignant</condition>
  <arm_group>
    <arm_group_label>Iodopovidone 1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Iodopovidone 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pleurodesis</intervention_name>
    <description>Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion</description>
    <arm_group_label>Iodopovidone 1%</arm_group_label>
    <arm_group_label>Iodopovidone 2%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  malignant pleural effusion&#xD;
&#xD;
          -  Recurrent pleural effusion&#xD;
&#xD;
          -  Complete lung expansion (&gt; 80%) after puncture emptying confirmed by chest&#xD;
             radiography.&#xD;
&#xD;
          -  Karnofsky index &gt; 40.&#xD;
&#xD;
          -  Agreed to participate in the study and sign an Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thrombocytopenia or coagulation disorders&#xD;
&#xD;
          -  Patients with impaired renal function&#xD;
&#xD;
          -  Pleural or active systemic infection&#xD;
&#xD;
          -  Massive neoplastic infiltration of the skin&#xD;
&#xD;
          -  Inability to understand the quality of life questionnaire&#xD;
&#xD;
          -  Previous pleural procedures&#xD;
&#xD;
          -  Allergy to iodine&#xD;
&#xD;
          -  Thyroid disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo M Terra, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>InCor Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Aristides Maltez</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <zip>40285-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>May 12, 2014</last_update_submitted>
  <last_update_submitted_qc>May 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2014</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>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</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/NCT01670786
org study id: GPPOT-02
nct id: NCT01670786
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural
      effusion, with minimal adverse events, especially reducing dose.
Background: Chemical pleurodesis is the treatment of choice in most cases of malignant
      pleural effusion. The literature mentions a variety of chemicals which may be used for this
      purpose, each with its own advantages and disadvantages. The iodopovidone has been recently
      studied due to the existence of some side effects of other agents. Nevertheless, there are
      still some questions in the literature regarding its safety and possible adverse effects.
      Because of these questions, we propose the development of a study to ensure the safety and
      efficacy of iodopovidone as a pleurodesis sclerosing agent.

      Objective: The main purpose of this study is to evaluate the safety of pleurodesis for
      malignant pleural effusion using iodopovidone as a sclerosing agent in different doses. The
      secondary objectives are to determine clinical efficacy and quality of life of the patients
      after realization of the proposed procedure.

      Methods: There will be a randomized clinical trial, covering patients diagnosed with
      malignant pleural effusion at Hospital Aristides Maltez - Bahia League Against Cancer. The
      research was revised and approved by the Ethics in Research of the Heart Institute, Hospital
      das Clínicas - FMUSP and of the Hospital Aristides Maltez - Bahia League Against Cancer. The
      free and informed consent was evaluated by the same authority pursuant and the study group
      included only those who agree to participate and signed an approved. There included patients
      with malignant pleural effusion diagnosis. Main exclusion criteria were iodine allergia,
      renal failure, thyroid disease, refusal to sign the informed consent and patients unable to
      respond the quality of life questionnaire. After inclusion, patients were randomized and
      assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All
      procedures were performed by infusion of the solution through a chest tube previously
      placed.The data analysis involved clinical measures and complementary exams trying to
      evaluate all organ systems and sorting through possible adverse effects, classifying those as
      CTCAEV. Clinical measures involved MRC dyspnea schedule, analogic visual pain schedule,
      visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and
      temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.
      Such measures were performed in the preoperative, immediate postoperative, second, fourth,
      eleventh and thirty days postoperative. Quality of life questionnaires was applied before and
      on thirty days postoperative as well. After that, randomized groups were compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety of iodopovidone as an agent for pleurodesis
time frame: Until 30th day after surgical procedure
description: The safety was assessed by mean clinical measures as MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.
measure: Quality of life
time frame: Until 1 week before the procedure date and 1 month after it
description: Quality of life questionnaires were applied until 1 week before the procedure date and on thirty days postoperative as well.
measure: Efficacy of iodopovidone as an agent for pleurodesis
time frame: Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure
description: The efficacy assessment was based on need of additional pleural surgical procedures.
arm group label: Iodopovidone 1%
arm group type: Experimental
description: The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity.
arm group label: Iodopovidone 2%
arm group type: Experimental
description: The patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity.
intervention type: Procedure
intervention name: pleurodesis
description: Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
arm group label: Iodopovidone 1%
arm group label: Iodopovidone 2%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ricardo M Terra, MD, PhD
role: Study Chair
affiliation: InCor Heart Institute
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion