<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/NCT04491123</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL19_0065</org_study_id>
    <nct_id>NCT04491123</nct_id>
  </id_info>
  <brief_title>Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms</brief_title>
  <acronym>IT-ESAS</acronym>
  <official_title>Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut du Cancer de Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oncopole Toulouse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or&#xD;
      intractable pain. The aim of this approach is to improve pain management, and also to improve&#xD;
      patient comfort. This study will assess patient discomfort symptoms before and after setting&#xD;
      up intrathecal analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Descriptive multicenter study including patients with refractory cancer pain (unmanageable&#xD;
      drug sides effects or intractable pain) who will receive intrathecal analgesia Patient&#xD;
      discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia&#xD;
      at 15, 30, 60 and 90 days.&#xD;
&#xD;
      Moreover, the impact on patient close relatives and on return home will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number Evaluation of Edmonton symptoms</measure>
    <time_frame>up to 90 days after patient inclusion</time_frame>
    <description>Edmonton symptom assessment system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autonomy assessment score for activities of daily living</measure>
    <time_frame>1 day</time_frame>
    <description>Autonomy assessment score for activities of daily living</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Refractory Cancer Pain</condition>
  <condition>Intrathecal Analgesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        cancer patients with refractory localized cancer pain because of drug side effects or&#xD;
        intractable pain who will receive intrathecal analgesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patients aged 18 and older&#xD;
&#xD;
          -  obligation of affiliation or beneficiary of a social security scheme&#xD;
&#xD;
          -  patients with cancer and refractory localized cancer pain because of drug side effects&#xD;
             or intractable pain&#xD;
&#xD;
          -  localized pain in topography accessible to intrathecal analgesia (legs, abdomen and&#xD;
             pelvis, pancoast-tobias symdrom)&#xD;
&#xD;
          -  patient's informed consent for the study&#xD;
&#xD;
          -  patient able to complete the evaluation questionnaires&#xD;
&#xD;
          -  estimed vital prognosis more than three month&#xD;
&#xD;
          -  patient with all conditions for intrathecal anagelsia&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  patient with intracranial hypertension&#xD;
&#xD;
          -  refusal of patient to be included in the study&#xD;
&#xD;
          -  refusal of patient to receive intrathecal analgesia&#xD;
&#xD;
          -  patient with many refractory pain localizations not accessible to intrathecal&#xD;
             analgesia&#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>Raphael RENAMBATZ-ICHAMBE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Refractory cancer pain</keyword>
  <keyword>intrathecal analgesia</keyword>
  <keyword>pain management</keyword>
  <keyword>discomfort symptoms management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- 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/NCT04491123
org study id: RECHMPL19_0065
nct id: NCT04491123
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or
      intractable pain. The aim of this approach is to improve pain management, and also to improve
      patient comfort. This study will assess patient discomfort symptoms before and after setting
      up intrathecal analgesia.
Descriptive multicenter study including patients with refractory cancer pain (unmanageable
      drug sides effects or intractable pain) who will receive intrathecal analgesia Patient
      discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia
      at 15, 30, 60 and 90 days.

      Moreover, the impact on patient close relatives and on return home will be assessed.
observational model: Case-Only
time perspective: Prospective
measure: Number Evaluation of Edmonton symptoms
time frame: up to 90 days after patient inclusion
description: Edmonton symptom assessment system
measure: Autonomy assessment score for activities of daily living
time frame: 1 day
description: Autonomy assessment score for activities of daily living
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raphael RENAMBATZ-ICHAMBE
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Cancer Pain
sharing ipd: Undecided
ipd description: NC