xml: <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/NCT06037902</url>
    </required_header>
    <id_info>
      <org_study_id>SHEBA-22-0032-YL-CTIL</org_study_id>
      <nct_id>NCT06037902</nct_id>
    </id_info>
    <brief_title>CPAP for Esophageal Cancer With Radiotherapy</brief_title>
    <acronym>TROS-7</acronym>
    <official_title>Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheba Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheba Medical Center</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer&#xD;
        undergoing radiotherapy.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  does use of CPAP decrease exposure of normal lung to radiation?&#xD;
  &#xD;
          -  does use of CPAP decrease exposure of normal heart to radiation?&#xD;
  &#xD;
        Participants will undergo simulation twice:&#xD;
  &#xD;
          -  with CPAP&#xD;
  &#xD;
          -  without CPAP&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</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>
      <intervention_model_description>all patients undergo two simulations.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>absolute mean heart radiation dose</measure>
      <time_frame>on day of simulation (day 1)</time_frame>
      <description>measured in Gy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lung dose in Gy</measure>
      <time_frame>on day of simulation (day 1)</time_frame>
      <description>mean lung dose, V5 and V20</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart dose in Gy</measure>
      <time_frame>on day of simulation (day 1)</time_frame>
      <description>mean heart dose, V30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>movement of tumor in cm</measure>
      <time_frame>on day of simulation (day 1)</time_frame>
      <description>how much tumor moves with breathing</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Esophageal Cancer</condition>
    <arm_group>
      <arm_group_label>CPAP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will undergo simulation twice, with and without CPAP</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CPAP</intervention_name>
      <description>patients undergo simulation twice, with and without CPAP</description>
      <arm_group_label>CPAP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including&#xD;
               tumors in the esophagus-stomach junction.&#xD;
  &#xD;
            2. Age ≥ 18&#xD;
  &#xD;
            3. Planned RT treatment&#xD;
  &#xD;
            4. The level of functioning ≥ 60 on the Karnofsky scale&#xD;
  &#xD;
            5. Life expectancy ≥ two months&#xD;
  &#xD;
            6. All patients must understand the informed consent form document and sign it of their&#xD;
               own free will before any test/procedure related to the study is performed.&#xD;
  &#xD;
            7. Able to undergo simulation and radiation with CPAP&#xD;
  &#xD;
            8. Candidate patients can be recruited to receive definitive, palliative or pre-operative&#xD;
               radiation, with or without chemotherapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A person who meets any of the following exclusion criteria will not be able to participate&#xD;
          in the study:&#xD;
  &#xD;
            1. Pregnancy or breastfeeding&#xD;
  &#xD;
            2. Significant comorbidity at the starting point that would prevent the use of CPAP&#xD;
  &#xD;
            3. Hospitalized in an institution by virtue of an administrative order or a court order.&#xD;
  &#xD;
            4. Special population&#xD;
  &#xD;
            5. A history of a psychiatric problem that may impair the patient's ability to understand&#xD;
               the research requirements or respond to them, or to give his consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sheba Medical Center</name>
        <address>
          <city>Ramat Gan</city>
          <zip>52621</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yaacov R Lawrence, MBBS MA MRCP</last_name>
        <phone>97235304410</phone>
        <email>Yaacov.Lawrence@sheba.health.gov.il</email>
      </contact>
      <contact_backup>
        <last_name>Aliza Ackerstein</last_name>
        <phone>035308402</phone>
        <email>aliza.ackerstein@sheba.health.gov.il</email>
      </contact_backup>
      <investigator>
        <last_name>Yaacov R Lawrence, MBBS MA MRCP</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
      <investigator_full_name>Dr. Yaacov Lawrence</investigator_full_name>
      <investigator_title>Chair of Department of Radiation Oncology, principal investigator</investigator_title>
    </responsible_party>
    <keyword>radiation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037902
  org study id: SHEBA-22-0032-YL-CTIL
  nct id: NCT06037902
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer
        undergoing radiotherapy.
  
        The main questions it aims to answer are:
  
          -  does use of CPAP decrease exposure of normal lung to radiation?
  
          -  does use of CPAP decrease exposure of normal heart to radiation?
  
        Participants will undergo simulation twice:
  
          -  with CPAP
  
          -  without CPAP
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: all patients undergo two simulations.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: absolute mean heart radiation dose
  time frame: on day of simulation (day 1)
  description: measured in Gy
  measure: lung dose in Gy
  time frame: on day of simulation (day 1)
  description: mean lung dose, V5 and V20
  measure: heart dose in Gy
  time frame: on day of simulation (day 1)
  description: mean heart dose, V30
  measure: movement of tumor in cm
  time frame: on day of simulation (day 1)
  description: how much tumor moves with breathing
  arm group label: CPAP
  arm group type: Experimental
  description: patients will undergo simulation twice, with and without CPAP
  intervention type: Device
  intervention name: CPAP
  description: patients undergo simulation twice, with and without CPAP
  arm group label: CPAP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Sheba Medical Center
  investigator full name: Dr. Yaacov Lawrence
  investigator title: Chair of Department of Radiation Oncology, principal investigator
  mesh term: Esophageal Neoplasms
  sharing ipd: No