<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/NCT03042195</url>
  </required_header>
  <id_info>
    <org_study_id>H-16042979</org_study_id>
    <nct_id>NCT03042195</nct_id>
  </id_info>
  <brief_title>Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients</brief_title>
  <acronym>SpPN-HNC</acronym>
  <official_title>Supplementary Postoperative Parenteral Nutrition for Head and Neck Cancer Patients - A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine whether postoperative nutrition with endeavours of&#xD;
      100% coverage of the patient's estimated energy and protein needs, can reduce the incidence&#xD;
      of postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Infectious Complications</measure>
    <time_frame>At day 30</time_frame>
    <description>Local and systemic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Thrombotic Complications</measure>
    <time_frame>At day 30</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fistula formation without infection defined by journal documentation</measure>
    <time_frame>Day 1,2,3,4,7,14, 23 and 30</time_frame>
    <description>The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who develop Refeeding Syndrome defined as a decrease in p-phosphate and clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.</measure>
    <time_frame>Day 2,3,4</time_frame>
    <description>Data are collected from the patient's record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who develop Refeeding Phenomena defined as a decrease in p-phosphate without clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.</measure>
    <time_frame>Day 2,3,4</time_frame>
    <description>Data will be collected from the patient's record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay at the hospital</measure>
    <time_frame>Up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.</measure>
    <time_frame>Day 1,2,3,4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.</measure>
    <time_frame>Day 1,2,3, 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.</measure>
    <time_frame>Baseline and Day 2,3,4</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).</measure>
    <time_frame>Baseline and Day 2,3,4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.</measure>
    <time_frame>Baseline and Day 2,3,4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).</measure>
    <time_frame>Day 2,3,4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Presence of oedema measured by weight in kg.</measure>
    <time_frame>Day 2,3,4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.</measure>
    <time_frame>Day 2,3,4</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Presence of vomiting under treatment registered by patient reported cases.</measure>
    <time_frame>Day 2,3,4</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Head and Neck Neoplasm</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supplementary parenteral nutrition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive standard nutritional care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parenteral Nutrition</intervention_name>
    <description>Supplementary parenteral nutrition to achieve 100% coverage of estimated needs</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who completed head and neck cancer surgery and got a feeding tube&#xD;
             perioperatively&#xD;
&#xD;
          -  Patients of legal age&#xD;
&#xD;
          -  Patients who can understand and read Scandinavian languages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergy to components in parenteral nutrition&#xD;
&#xD;
          -  Patients where it is impossible to give parenteral nutrition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinic for Ear, Nose and Throat Surgery, Rigshospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100 Cph OE</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Supplementary Parenteral Nutrition</keyword>
  <keyword>Postoperative Nutrition</keyword>
  <keyword>Postoperative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT03042195
org study id: H-16042979
nct id: NCT03042195
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to examine whether postoperative nutrition with endeavours of
      100% coverage of the patient's estimated energy and protein needs, can reduce the incidence
      of postoperative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Postoperative Infectious Complications
time frame: At day 30
description: Local and systemic
measure: Postoperative Thrombotic Complications
time frame: At day 30
measure: Fistula formation without infection defined by journal documentation
time frame: Day 1,2,3,4,7,14, 23 and 30
description: The measurement that will be used is documented fistula formation in the patients´ journal without increased infection parameters (c-reactive protein and leukocytes)
measure: Number of participants who develop Refeeding Syndrome defined as a decrease in p-phosphate and clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.
time frame: Day 2,3,4
description: Data are collected from the patient's record.
measure: Number of participants who develop Refeeding Phenomena defined as a decrease in p-phosphate without clinical symptoms of refeeding syndrome; edema, dyspnea, hypertension, arrhythmia, confusion and/ or cases of spasm.
time frame: Day 2,3,4
description: Data will be collected from the patient's record.
measure: Length of stay at the hospital
time frame: Up to 30 days
measure: Coverage of energy requirement, estimated by the Harris Benedict formula. Coverage is estimated by daily dietary registration.
time frame: Day 1,2,3,4
measure: Coverage of protein requirement, estimated in g/kg/day. The coverage is estimated by daily dietary registration.
time frame: Day 1,2,3, 4
measure: Hand Grip Strength measured by a hand grip strength dynamometer in kilograms.
time frame: Baseline and Day 2,3,4
measure: Biochemical Changes in Liver Parameters; p-alanine aminotransferase, p-bilirubin, alkaline phosphatase and INR (international normalized ratio).
time frame: Baseline and Day 2,3,4
measure: Number of patients who develop coagulopathy defined as increase in INR (international normalized ratio) above the reference level.
time frame: Baseline and Day 2,3,4
measure: Presence of nausea under treatment measured by a VAS-scale (visual analogue scale).
time frame: Day 2,3,4
measure: Presence of oedema measured by weight in kg.
time frame: Day 2,3,4
measure: Causes of insufficient dietary intake, measured by a questionnaire filled out by the patient.
time frame: Day 2,3,4
measure: Presence of vomiting under treatment registered by patient reported cases.
time frame: Day 2,3,4
arm group label: Intervention group
arm group type: Active Comparator
description: Supplementary parenteral nutrition
arm group label: Control group
arm group type: No Intervention
description: The control group will receive standard nutritional care
intervention type: Other
intervention name: Parenteral Nutrition
description: Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Associate Professor
mesh term: Head and Neck Neoplasms
sharing ipd: No