<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/NCT04469504</url>
  </required_header>
  <id_info>
    <org_study_id>2017_06</org_study_id>
    <secondary_id>2019-A00632-55</secondary_id>
    <nct_id>NCT04469504</nct_id>
  </id_info>
  <brief_title>Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer</brief_title>
  <acronym>PSOAS</acronym>
  <official_title>Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Groupement Interrégional de Recherche Clinique et d'Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Santelys Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Major digestive surgery is associated with a significant rate of postoperative complications.&#xD;
      To improve postoperative outcome, efforts are focused on postoperative course leading to the&#xD;
      concept of rehabilitation. However, the rehabilitation concept does not allow to improve&#xD;
      muscular and functional reserves at the time of surgery. Sarcopenia is a condition&#xD;
      characterized by loss of skeletal muscle mass and function. Also, the prevalence of&#xD;
      sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients&#xD;
      with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.&#xD;
&#xD;
      The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could&#xD;
      improve patients' operative outcomes by reducing the rate of postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 17, 2022</start_date>
  <completion_date type="Anticipated">May 2028</completion_date>
  <primary_completion_date type="Anticipated">May 2028</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative severe pancreatic fistula (Grade B and C)</measure>
    <time_frame>at 90 days</time_frame>
    <description>Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Severe postoperative complications</measure>
    <time_frame>at 90 days</time_frame>
    <description>Grade &gt; IIIa (Clavien-Dindo classification)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>at 1 year and at 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program acceptance measure by Modified ACCEPT© questionnaire</measure>
    <time_frame>at 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of program completion</measure>
    <time_frame>at 30 days</time_frame>
    <description>self questionnaire to measure opinion with respect of rehabilitation program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction questionnaire by EVAN-G</measure>
    <time_frame>at 30 days</time_frame>
    <description>EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)</measure>
    <time_frame>at 30 days</time_frame>
    <description>French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by EORTC-QLQc30 scale</measure>
    <time_frame>at 1 month, 3 months, 6 months and at 1 year</time_frame>
    <description>The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">158</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>PREHAB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation program</intervention_name>
    <description>4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support</description>
    <arm_group_label>PREHAB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral Impact</intervention_name>
    <description>perioperative immunonutrition by ORAL IMPACT</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing pancreaticoduodenectomy for cancer&#xD;
&#xD;
          -  Sarcopenic status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 years&#xD;
&#xD;
          -  Medical contraindications including cardiovascular disease or clinically significant&#xD;
             vascular disease&#xD;
&#xD;
          -  Physical inability to exercise&#xD;
&#xD;
          -  Emergent surgery&#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>Mehdi ELAMRANI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mehdi ELAMRANI, MD</last_name>
    <phone>0320444465</phone>
    <phone_ext>+33</phone_ext>
    <email>mehdi.elamrani@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hop Claude Huriez Chu Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>morbimortality</keyword>
  <keyword>Prehabilitaion</keyword>
  <keyword>pancreatic surgery</keyword>
  <keyword>cephalic duodenopancreatectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</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/NCT04469504
org study id: 2017_06
secondary id: 2019-A00632-55
nct id: NCT04469504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Major digestive surgery is associated with a significant rate of postoperative complications.
      To improve postoperative outcome, efforts are focused on postoperative course leading to the
      concept of rehabilitation. However, the rehabilitation concept does not allow to improve
      muscular and functional reserves at the time of surgery. Sarcopenia is a condition
      characterized by loss of skeletal muscle mass and function. Also, the prevalence of
      sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients
      with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

      The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could
      improve patients' operative outcomes by reducing the rate of postoperative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Post-operative severe pancreatic fistula (Grade B and C)
time frame: at 90 days
description: Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)
measure: Rate of Severe postoperative complications
time frame: at 90 days
description: Grade > IIIa (Clavien-Dindo classification)
measure: Overall survival
time frame: at 1 year and at 3 years
measure: Program acceptance measure by Modified ACCEPT© questionnaire
time frame: at 30 days
measure: Rate of program completion
time frame: at 30 days
description: self questionnaire to measure opinion with respect of rehabilitation program
measure: Satisfaction questionnaire by EVAN-G
time frame: at 30 days
description: EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.
measure: Satisfaction questionnaire by the questionnaire for satisfaction of hospitalized (QSH-45)
time frame: at 30 days
description: French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)
measure: Quality of life by EORTC-QLQc30 scale
time frame: at 1 month, 3 months, 6 months and at 1 year
description: The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.
arm group label: PREHAB
arm group type: Experimental
arm group label: control group
arm group type: Active Comparator
intervention type: Other
intervention name: Prehabilitation program
description: 4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
arm group label: PREHAB
intervention type: Dietary Supplement
intervention name: Oral Impact
description: perioperative immunonutrition by ORAL IMPACT
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mehdi ELAMRANI, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Mehdi ELAMRANI, MD
phone: 0320444465
phone ext: +33
email: mehdi.elamrani@chru-lille.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Sarcopenia