<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/NCT02199912</url>
  </required_header>
  <id_info>
    <org_study_id>2012.752</org_study_id>
    <secondary_id>2012-A01017-36</secondary_id>
    <nct_id>NCT02199912</nct_id>
  </id_info>
  <brief_title>Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery</brief_title>
  <acronym>ANC2</acronym>
  <official_title>ANC2 Pilot Study Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cachexia associated with cancer is a grave and most of the time irreversible common&#xD;
      situation. It seems independent from the size of the tumor or from its metastatic character.&#xD;
      The consequences for the management of the patient are major and exceed widely the frame of&#xD;
      the nutrition.&#xD;
&#xD;
      Undernutrition of patients with cancer is described by a decrease of the energy contributions&#xD;
      and a loss of muscular and fat mass, leading to a progressive functional deficiency which can&#xD;
      go to the cachectic state.&#xD;
&#xD;
      Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia&#xD;
      but it remain too indistinct to allow an early and efficient screening and set up effective&#xD;
      measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast&#xD;
      iron of the energy reserves.&#xD;
&#xD;
      It is necessary to have clinical and biological markers with diagnostic aim and forecasts&#xD;
      during the situations precedents the appearance of cachexia.&#xD;
&#xD;
      The present study will allow calibrating a longitudinal study, which could confirm the value&#xD;
      of measures made for the diagnosis of pre-cachexia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2013</start_date>
  <completion_date type="Actual">March 7, 2018</completion_date>
  <primary_completion_date type="Actual">February 7, 2018</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biological and radiological markers</measure>
    <time_frame>During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)</time_frame>
    <description>Validated criteria of cachexia, pre-cachexia and sarcopenia are applied. Systematic preoperative measures (TNFα, leptin, ghrelin) and CT scanning of the abdomen/pelvis are performed for all patient enrolled.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>activity of the ATGL</measure>
    <time_frame>During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)</time_frame>
    <description>The activity of ATGL is determined by liquid scintillation counting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)</time_frame>
    <description>Body composition is evaluated utilizing computerized tomography(CT) images (at the third lumbar vertebral level). A muscle index is also calculated by normalizing muscle areas for height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic phenotype</measure>
    <time_frame>During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)</time_frame>
    <description>metabolic phenotype is determinated by indirect calorimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>loss of fat body mass and/or lean body mass</measure>
    <time_frame>During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)</time_frame>
    <description>Lean body mass and components (intracellular water and extracellular water as well as body cell mass) were calculated by tetrapolar bioelectrical impedance analysis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Colorectal Tumor</condition>
  <arm_group>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy of adipose and muscular tissue</intervention_name>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calorimetry</intervention_name>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Impedance measure</intervention_name>
    <description>Evaluation of physical composition (non-invasive method)</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of nutritional status</intervention_name>
    <description>Nutritional status will be assessed by using the &quot;Mini Nutritional Assessment&quot; (MNA) questionnaire and a scale that evaluates anorexia</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of physical performance</intervention_name>
    <description>This will be assessed by using a &quot;tiredness scale&quot; named &quot;Echelle Visuelle Analogique&quot; (EVA) in french</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of muscular strength</intervention_name>
    <description>Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of emotional status</intervention_name>
    <description>The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation of functional status</intervention_name>
    <description>The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire</description>
    <arm_group_label>Patients with colorectal surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 70 years&#xD;
&#xD;
          -  Colorectal tumor resection with/without synchronous metastases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency resection of colorectal tumor&#xD;
&#xD;
          -  Unresectable colorectal tumor with/without synchronous metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupement Hospitalier Sud - Service de Médecine Gériatrique</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cachexia</keyword>
  <keyword>nutrition</keyword>
  <keyword>cancer</keyword>
  <keyword>colorectal tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Cachexia</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/NCT02199912
org study id: 2012.752
secondary id: 2012-A01017-36
nct id: NCT02199912
lead sponsor: 
has dmc: No
Cachexia associated with cancer is a grave and most of the time irreversible common
      situation. It seems independent from the size of the tumor or from its metastatic character.
      The consequences for the management of the patient are major and exceed widely the frame of
      the nutrition.

      Undernutrition of patients with cancer is described by a decrease of the energy contributions
      and a loss of muscular and fat mass, leading to a progressive functional deficiency which can
      go to the cachectic state.

      Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia
      but it remain too indistinct to allow an early and efficient screening and set up effective
      measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast
      iron of the energy reserves.

      It is necessary to have clinical and biological markers with diagnostic aim and forecasts
      during the situations precedents the appearance of cachexia.

      The present study will allow calibrating a longitudinal study, which could confirm the value
      of measures made for the diagnosis of pre-cachexia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: biological and radiological markers
time frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
description: Validated criteria of cachexia, pre-cachexia and sarcopenia are applied. Systematic preoperative measures (TNFα, leptin, ghrelin) and CT scanning of the abdomen/pelvis are performed for all patient enrolled.
measure: activity of the ATGL
time frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
description: The activity of ATGL is determined by liquid scintillation counting.
measure: Body composition
time frame: During perioperative period (from date of consent until discharge from the hospital, up to 30 postoperative days)
description: Body composition is evaluated utilizing computerized tomography(CT) images (at the third lumbar vertebral level). A muscle index is also calculated by normalizing muscle areas for height.
measure: metabolic phenotype
time frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
description: metabolic phenotype is determinated by indirect calorimetry.
measure: loss of fat body mass and/or lean body mass
time frame: During perioperative period (From date of consent until discharge from the hospital, up to 30 postoperative days)
description: Lean body mass and components (intracellular water and extracellular water as well as body cell mass) were calculated by tetrapolar bioelectrical impedance analysis
arm group label: Patients with colorectal surgery
arm group type: Experimental
intervention type: Procedure
intervention name: Biopsy of adipose and muscular tissue
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Blood sampling
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Calorimetry
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Impedance measure
description: Evaluation of physical composition (non-invasive method)
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Evaluation of nutritional status
description: Nutritional status will be assessed by using the "Mini Nutritional Assessment" (MNA) questionnaire and a scale that evaluates anorexia
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Evaluation of physical performance
description: This will be assessed by using a "tiredness scale" named "Echelle Visuelle Analogique" (EVA) in french
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Evaluation of muscular strength
description: Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Evaluation of emotional status
description: The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
arm group label: Patients with colorectal surgery
intervention type: Other
intervention name: Evaluation of functional status
description: The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire
arm group label: Patients with colorectal surgery
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Wasting Syndrome
mesh term: Cachexia