<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/NCT01700062</url>
  </required_header>
  <id_info>
    <org_study_id>KMUH-IRB-960022</org_study_id>
    <nct_id>NCT01700062</nct_id>
  </id_info>
  <brief_title>Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery</brief_title>
  <official_title>Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or&#xD;
      standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer&#xD;
      undergoing surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      biochemistry data Various inflammation-related cytokines clinical outcome hospital stay&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2007</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">November 2008</primary_completion_date>
  <phase>Phase 4</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biochemistry data; Various inflammation-related cytokines ;</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical outcome(hospital stay..)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Medium calorie</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>standard calorie</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Total Parenteral Nutrition (TPN)</intervention_name>
    <description>Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP</description>
    <arm_group_label>Medium calorie</arm_group_label>
    <arm_group_label>standard calorie</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients considered for major surgery for colorectal cancer Expected requirement for&#xD;
             post operative PN or TPN of at least for 7 days Age &gt;18 Hemodynamically stable Written&#xD;
             Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamic failure of any organ Renal insufficiency Patients with severe liver&#xD;
             dysfunction Albumin &lt; 3g/dL DM with poor blood sugar control&#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>JF CHUANG, M.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>JY WANG, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YB HUANG, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Medical University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</investigator_affiliation>
    <investigator_full_name>JUI-FEN CHUANG</investigator_full_name>
    <investigator_title>Department of pharmacy, leader</investigator_title>
  </responsible_party>
  <keyword>medium-calorie</keyword>
  <keyword>standard calorie</keyword>
  <keyword>parenteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal 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/NCT01700062
org study id: KMUH-IRB-960022
nct id: NCT01700062
lead sponsor: 
has dmc: Yes
aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or
      standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer
      undergoing surgery
biochemistry data Various inflammation-related cytokines clinical outcome hospital stay
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: biochemistry data; Various inflammation-related cytokines ;
time frame: 7 days
measure: clinical outcome(hospital stay..)
time frame: 2 months
arm group label: Medium calorie
arm group type: Experimental
arm group label: standard calorie
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Total Parenteral Nutrition (TPN)
description: Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP
arm group label: Medium calorie
arm group label: standard calorie
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JF CHUANG, M.S.
role: Principal Investigator
affiliation: Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
last name: JY WANG, M.D.
role: Study Chair
affiliation: Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
last name: YB HUANG, Ph.D.
role: Study Director
affiliation: Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
investigator full name: JUI-FEN CHUANG
investigator title: Department of pharmacy, leader
mesh term: Colorectal Neoplasms
mesh term: Gastrointestinal Neoplasms