<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/NCT02184663</url>
  </required_header>
  <id_info>
    <org_study_id>APACaP D13-1</org_study_id>
    <secondary_id>2014-A00228-39</secondary_id>
    <nct_id>NCT02184663</nct_id>
  </id_info>
  <brief_title>Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer</brief_title>
  <official_title>Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GERCOR - Multidisciplinary Oncology Cooperative Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for&#xD;
      patients with unresectable pancreatic cancer.&#xD;
&#xD;
      Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such&#xD;
      population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis&#xD;
      in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life,&#xD;
      psychological and emotional state, and adherence to treatment.&#xD;
&#xD;
      The aim of the study is to assess the effects of an APA program in pancreatic cancer&#xD;
      population treated by usual chemotherapy.&#xD;
&#xD;
      200 randomized patients are required.&#xD;
&#xD;
      The program is organized in 16 weeks. During the trial, assessments include: aerobic&#xD;
      exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3&#xD;
      CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ&#xD;
      questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire),&#xD;
      quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire),&#xD;
      depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain&#xD;
      (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).&#xD;
&#xD;
      Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth&#xD;
      Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in&#xD;
      decreasing insulin-resistance, insulin secretion and IGF-1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 15, 2014</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">April 23, 2022</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Multidimensional Fatigue Inventory - (MFI-20 questionnaire)</measure>
    <time_frame>At 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life - EORTC Quality of Life Questionnaire C-30 - (EORTC QLQ-30 questionnaire)</measure>
    <time_frame>At 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time To deterioration (TTD)</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory Short form questionnaire</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient depression scale - HADS questionnaire</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status evaluation</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity evaluation - IPAQ questionnaire</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse events (AE) grade 3 -4</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accompanying partner depression scale (HADS questionnaire)</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General state - Performance status OMS</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue scale (EVA fatigue)</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MFI-20 and EORTC QLQ C-30 evaluation</measure>
    <time_frame>at 6, 12 et 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>medico-economic evaluation</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual analog scale for pain</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic consumption</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiolytic / antidepressant consumption</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">313</enrollment>
  <condition>Unresectable Locally Advanced Cancer</condition>
  <condition>Metastatic Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Standard care without APA program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care with APA program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>without APA program</intervention_name>
    <description>Control Arm : chemotherapy alone</description>
    <arm_group_label>Standard care without APA program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>APA program</intervention_name>
    <description>Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)</description>
    <arm_group_label>standard care with APA program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven non resectable pancreatic adenocarcinoma&#xD;
&#xD;
          -  Indication of palliative chemotherapy&#xD;
&#xD;
          -  Life expectancy ≥ 3 months&#xD;
&#xD;
          -  Eastern Cooperative oncology group (ECOG) - Performance status ≤2&#xD;
&#xD;
          -  Age ≥18 years old&#xD;
&#xD;
          -  At least one measurable lesion as assessed by CT-scan or MRI (Magnetic resonance&#xD;
             Imaging)&#xD;
&#xD;
          -  Identified Accompanying partner Adapted Physical Activity (AAPA)&#xD;
&#xD;
          -  Signed and dated informed consent&#xD;
&#xD;
          -  Registration in a National Health Care System (CMU included for France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous Cerebrovascular accident or myocardial infarction &lt;6months&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Severe cardiovascular or respiratory disease&#xD;
&#xD;
          -  Severe cognitive or psychiatric disorder&#xD;
&#xD;
          -  Severe motor and/or sensory neuropathy&#xD;
&#xD;
          -  Rheumatologic or orthopedic problem or bone lesions with a fracture risk&#xD;
&#xD;
          -  Others comorbidities contra-indicated physical exercises&#xD;
&#xD;
          -  Patient protected by the law - Guardianship and trusteeship&#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>Pascal Hammel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Beaujon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Polyclinique Bordeaux Nord Aquitaine</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Morvan</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges François Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche Sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois Perret</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint Joseph Saint Luc</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Mont de Marsan</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Belfort</name>
      <address>
        <city>Montbéliard</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Robert Debré</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital FOCH</name>
      <address>
        <city>Suresnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de cancérologie de Lorraine</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Unresectable</keyword>
  <keyword>Pancreatic cancer</keyword>
  <keyword>GERCOR</keyword>
  <keyword>Adapted physical activity (APA)</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT02184663
org study id: APACaP D13-1
secondary id: 2014-A00228-39
nct id: NCT02184663
lead sponsor: 
has dmc: No
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for
      patients with unresectable pancreatic cancer.

      Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such
      population
The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis
      in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life,
      psychological and emotional state, and adherence to treatment.

      The aim of the study is to assess the effects of an APA program in pancreatic cancer
      population treated by usual chemotherapy.

      200 randomized patients are required.

      The program is organized in 16 weeks. During the trial, assessments include: aerobic
      exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3
      CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ
      questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire),
      quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire),
      depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain
      (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

      Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth
      Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in
      decreasing insulin-resistance, insulin secretion and IGF-1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Multidimensional Fatigue Inventory - (MFI-20 questionnaire)
time frame: At 16 weeks
measure: Quality of life - EORTC Quality of Life Questionnaire C-30 - (EORTC QLQ-30 questionnaire)
time frame: At 16 weeks
measure: Time To deterioration (TTD)
time frame: Up to 24 months
measure: Brief Pain Inventory Short form questionnaire
time frame: Up to 24 months
measure: Patient depression scale - HADS questionnaire
time frame: Up to 24 months
measure: Nutritional status evaluation
time frame: up to 24 months
description: Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)
measure: Physical Activity evaluation - IPAQ questionnaire
time frame: up to 24 months
description: Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program
measure: Number of Adverse events (AE) grade 3 -4
time frame: up to 24 months
measure: Progression free survival (PFS)
time frame: 2 years
measure: Overall Survival (OS)
time frame: 2 years
measure: Accompanying partner depression scale (HADS questionnaire)
time frame: up to 24 months
measure: General state - Performance status OMS
time frame: up to 24 months
measure: Fatigue scale (EVA fatigue)
time frame: up to 24 months
measure: MFI-20 and EORTC QLQ C-30 evaluation
time frame: at 6, 12 et 24 months
measure: medico-economic evaluation
time frame: up to 24 months
measure: visual analog scale for pain
time frame: up to 24 months
measure: analgesic consumption
time frame: up to 24 months
measure: anxiolytic / antidepressant consumption
time frame: up to 24 months
arm group label: Standard care without APA program
arm group type: Active Comparator
arm group label: standard care with APA program
arm group type: Experimental
intervention type: Other
intervention name: without APA program
description: Control Arm : chemotherapy alone
arm group label: Standard care without APA program
intervention type: Other
intervention name: APA program
description: Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
arm group label: standard care with APA program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal Hammel, PhD
role: Principal Investigator
affiliation: Hôpital Beaujon
facility: 
facility: 
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country: France
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms