xml: <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/NCT06027242</url>
    </required_header>
    <id_info>
      <org_study_id>202207099RINA</org_study_id>
      <nct_id>NCT06027242</nct_id>
    </id_info>
    <brief_title>Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy</brief_title>
    <official_title>Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The&#xD;
        primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in&#xD;
        gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including&#xD;
        the physical activity, weight loss, and nutritional profiles, will be evaluated among these&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable&#xD;
        patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly&#xD;
        assigned to the control or treatment group. Each group will have at least 40 patients. The CT&#xD;
        scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the&#xD;
        patient will wear the smart watch to record daily walking steps. Laboratory data will be&#xD;
        check before gastrectomy and on POD 90.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 21, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2026</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of area of psoas muscle</measure>
      <time_frame>84 days after gastrectomy</time_frame>
      <description>area od psoas muscle on the CT scan</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Walking steps</measure>
      <time_frame>28,56, and 84 days after gastrectomy</time_frame>
      <description>the average daily walking steps recorded by the wearable devices</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>body weight</measure>
      <time_frame>84 days after gastrectomy</time_frame>
      <description>body weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of serum albumin value</measure>
      <time_frame>84 days after gastrectomy</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in white blood cells counts</measure>
      <time_frame>84 days after gastrectomy</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in lymphocyte cells counts</measure>
      <time_frame>84 days after gastrectomy</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of serum pre-albumin value</measure>
      <time_frame>84 days after gastrectomy</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Gastric Cancer</condition>
    <condition>Immunonutrition</condition>
    <condition>Gastrostomy</condition>
    <arm_group>
      <arm_group_label>Without oral glutamine supplementation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding</description>
    </arm_group>
    <arm_group>
      <arm_group_label>With oral glutamine supplementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>oral glutamine</intervention_name>
      <description>10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding</description>
      <arm_group_label>With oral glutamine supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Maltodextrin</intervention_name>
      <description>Maltodextrin</description>
      <arm_group_label>With oral glutamine supplementation</arm_group_label>
      <arm_group_label>Without oral glutamine supplementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult gastric cancer receiving gastrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hepatic insufficiency&#xD;
  &#xD;
            -  Renal insufficiency&#xD;
  &#xD;
            -  can not tolerate oral or enteral feeding 7 days after gastrectomy&#xD;
  &#xD;
            -  can not receive computed tomograph&#xD;
  &#xD;
            -  can not waer the wearable devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jin-Ming Wu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jin-Ming Wu, MD</last_name>
        <phone>886-223123456</phone>
        <email>wujm0531@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
      <investigator_full_name>National Taiwan University Clinical Trial Center</investigator_full_name>
      <investigator_title>Jin-Ming Wu, Clinical Associate Professor &amp; PhD</investigator_title>
    </responsible_party>
    <keyword>Gastric cancer</keyword>
    <keyword>Gastrectomy</keyword>
    <keyword>sarcopenia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>November 3, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT06027242/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027242
  org study id: 202207099RINA
  nct id: NCT06027242
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The
        primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in
        gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including
        the physical activity, weight loss, and nutritional profiles, will be evaluated among these
        patients.
  This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable
        patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly
        assigned to the control or treatment group. Each group will have at least 40 patients. The CT
        scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the
        patient will wear the smart watch to record daily walking steps. Laboratory data will be
        check before gastrectomy and on POD 90.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Change of area of psoas muscle
  time frame: 84 days after gastrectomy
  description: area od psoas muscle on the CT scan
  measure: Walking steps
  time frame: 28,56, and 84 days after gastrectomy
  description: the average daily walking steps recorded by the wearable devices
  measure: body weight
  time frame: 84 days after gastrectomy
  description: body weight
  measure: Change of serum albumin value
  time frame: 84 days after gastrectomy
  measure: Change in white blood cells counts
  time frame: 84 days after gastrectomy
  measure: Change in lymphocyte cells counts
  time frame: 84 days after gastrectomy
  measure: Change of serum pre-albumin value
  time frame: 84 days after gastrectomy
  arm group label: Without oral glutamine supplementation
  arm group type: Placebo Comparator
  description: 15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
  arm group label: With oral glutamine supplementation
  arm group type: Active Comparator
  description: 10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
  intervention type: Dietary Supplement
  intervention name: oral glutamine
  description: 10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
  arm group label: With oral glutamine supplementation
  intervention type: Dietary Supplement
  intervention name: Maltodextrin
  description: Maltodextrin
  arm group label: With oral glutamine supplementation
  arm group label: Without oral glutamine supplementation
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jin-Ming Wu, MD
  role: Principal Investigator
  affiliation: National Taiwan University Hospital
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University Hospital
  investigator full name: National Taiwan University Clinical Trial Center
  investigator title: Jin-Ming Wu, Clinical Associate Professor & PhD
  mesh term: Stomach Neoplasms
  sharing ipd: No
  provided document: 