<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/NCT03032224</url>
  </required_header>
  <id_info>
    <org_study_id>janpe4</org_study_id>
    <nct_id>NCT03032224</nct_id>
  </id_info>
  <brief_title>Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer</brief_title>
  <official_title>Analysis of Sarcopenia and Body Composition in Relation to Outcome in a Cohort of Patients With Esophageal Cancer or Cancer of the Gastroesophageal Junction Before and After Surgery With Curative Intent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Göteborg Medical Society, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The occurrence of dysphagia is a well-known early feature of esophageal cancer that may&#xD;
      reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a&#xD;
      consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in&#xD;
      patients with esophageal cancer before and after surgery is not well known and its possible&#xD;
      consequences have been debated.&#xD;
&#xD;
      Aim: The aim of this study was to prospectively explore body composition and function in a&#xD;
      cohort of patients with esophageal cancer before and after surgery with curative intent. In&#xD;
      particular, to investigate the prevalence and development of sarcopenia and body composition&#xD;
      as a consequence to surgery for esophageal cancer and the possible relation to morbidity,&#xD;
      length of stay and quality of life (QoL).&#xD;
&#xD;
      Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for&#xD;
      surgery with a curative intent, data on body-composition measured with bioimpedance, working&#xD;
      capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and&#xD;
      Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were&#xD;
      prospectively collected. Data regarding dysphagia was derived from an esophagus related&#xD;
      quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length&#xD;
      of stay and preoperative weight loss were collected from medical charts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2015</start_date>
  <completion_date type="Actual">July 23, 2020</completion_date>
  <primary_completion_date type="Actual">July 23, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Body mass index (BMI) kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent</measure>
    <time_frame>Three months</time_frame>
    <description>Weight kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Fat free mass (FFM) kg;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Fat mass (FM) kg;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Lean tissue mass (LTM) kg;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Total body water (TBW) l;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Intra cellular water (ICW) l;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Body composition after surgery for esophageal cancer with curative intent.</measure>
    <time_frame>Three months</time_frame>
    <description>Extra cellular water (ECW) l</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in QoL (linear scale 0-100)</measure>
    <time_frame>From surgery up to three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dysphagia (linear scale 0-100)</measure>
    <time_frame>From surgery up to three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay (days)</measure>
    <time_frame>From surgery up to three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications after surgery (Clavien-Dindo scale 0-5)</measure>
    <time_frame>From surgery up to three months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Length of survival after surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Cancer of Esophagus</condition>
  <condition>Gastric Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection of the esophagus and the gastroesophageal junction</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study was a prospective collected cohort study in 76 patients who were referred to the&#xD;
        surgery clinic at the Sahlgrenska University hospital 2005-2010. Patients with esophageal&#xD;
        cancer or cancer of the gastroesophageal junction (Siewert I or II), who were scheduled to&#xD;
        undergo resection surgery with curative intent, were asked to participate. Patients were&#xD;
        excluded if they were found to have an advanced tumour stage or if they declined&#xD;
        participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer of the gastro-esophageal junction or the esophagus.&#xD;
&#xD;
          -  Planned for curative surgery.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fulfilling the above.&#xD;
&#xD;
          -  Patient declined participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Surgical Department, Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <state>Västra Götalandsregionen</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Body composition</keyword>
  <keyword>sarcopenia</keyword>
  <keyword>Dysphagia</keyword>
  <keyword>Surgery</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Morbidity</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>


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/NCT03032224
org study id: janpe4
nct id: NCT03032224
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The occurrence of dysphagia is a well-known early feature of esophageal cancer that may
      reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a
      consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in
      patients with esophageal cancer before and after surgery is not well known and its possible
      consequences have been debated.

      Aim: The aim of this study was to prospectively explore body composition and function in a
      cohort of patients with esophageal cancer before and after surgery with curative intent. In
      particular, to investigate the prevalence and development of sarcopenia and body composition
      as a consequence to surgery for esophageal cancer and the possible relation to morbidity,
      length of stay and quality of life (QoL).

      Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for
      surgery with a curative intent, data on body-composition measured with bioimpedance, working
      capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and
      Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were
      prospectively collected. Data regarding dysphagia was derived from an esophagus related
      quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length
      of stay and preoperative weight loss were collected from medical charts.
observational model: Cohort
time perspective: Prospective
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Body mass index (BMI) kg/m2
measure: Changes in Body composition after surgery for esophageal cancer with curative intent
time frame: Three months
description: Weight kg
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Fat free mass (FFM) kg;
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Fat mass (FM) kg;
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Lean tissue mass (LTM) kg;
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Total body water (TBW) l;
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Intra cellular water (ICW) l;
measure: Changes in Body composition after surgery for esophageal cancer with curative intent.
time frame: Three months
description: Extra cellular water (ECW) l
measure: Changes in QoL (linear scale 0-100)
time frame: From surgery up to three months
measure: Changes in dysphagia (linear scale 0-100)
time frame: From surgery up to three months
measure: Length of stay (days)
time frame: From surgery up to three months
measure: Complications after surgery (Clavien-Dindo scale 0-5)
time frame: From surgery up to three months
measure: Mortality
time frame: Length of survival after surgery
intervention type: Procedure
intervention name: Resection of the esophagus and the gastroesophageal junction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: No