<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/NCT04456647</url>
  </required_header>
  <id_info>
    <org_study_id>2018/1500</org_study_id>
    <nct_id>NCT04456647</nct_id>
  </id_info>
  <brief_title>Parenteral Nutrition Therapy in Patients With Incurable Cancer</brief_title>
  <acronym>PATNIC</acronym>
  <official_title>Parenteral Nutrition Therapy in Patients With Incurable Cancer - A Retrospective Analysis of Current Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset i Vestfold HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the&#xD;
      level of evidence for clinical meaningful effects is weak. Guidelines give few specific&#xD;
      recommendations regarding which patients with incurable cancer that should be offered PN&#xD;
      treatment. According to the Norwegian prescription database, the use of parenteral nutrition&#xD;
      has more than doubled in the period 2004-2015. These numbers do not separate between&#xD;
      diagnoses and medical conditions, so the current use of medical nutrition in cancer patients&#xD;
      in Norway is not known. The decision to initiate parenteral nutrition is taken at hospitals,&#xD;
      whereupon the patient returns home to their respective municipalities and receives follow-up&#xD;
      by the home care service. There are often uncertainties about the duration of treatment, as&#xD;
      patients' clinical condition can change rapidly. One major challenge health care&#xD;
      professionals face is to decide when to end medical nutrition therapy. Patients and relatives&#xD;
      may experience fear that discontinuation of medical nutrition accelerates death, while health&#xD;
      care professionals often experience that nutrition in many cases does not help and inflicts&#xD;
      negatively on patients' condition. This makes communication concerning end of nutritional&#xD;
      treatment between health care professionals at several health care levels, patients and their&#xD;
      relatives challenging.&#xD;
&#xD;
      There is a need for a stronger evidence base considering the effect of medical nutrition in&#xD;
      patients with incurable cancer. To be able to study the effect of PN treatment, more studies&#xD;
      on clinical practice of PN treatment to patients with incurable cancer is needed. Aspects&#xD;
      like indication for use, dosage and duration of PN treatment is poorly described in the&#xD;
      available literature. Thus, the aim of this study is to describe indications for use of PN,&#xD;
      duration of treatment, reasons for discontinuation, method of administration, possible&#xD;
      benefits and complications as well as survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Received dose of parenteral nutrition</measure>
    <time_frame>From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years</time_frame>
    <description>Dose is measured in kcal/kg/day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of treatment</measure>
    <time_frame>From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years</time_frame>
    <description>Duration is measured in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>From start of parenteral nutrition treatment to date of death, up to 7 years</time_frame>
    <description>Survival is measured in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Indication for use of parenteral nutrition</measure>
    <time_frame>Baseline</time_frame>
    <description>Registered indication for use of parenteral nutrition treatment</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">507</enrollment>
  <condition>Neoplasms</condition>
  <condition>Terminal Illness</condition>
  <arm_group>
    <arm_group_label>Parenteral nutrition</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parenteral nutrition</intervention_name>
    <description>Parenteral nutrition treatment in palliative care</description>
    <arm_group_label>Parenteral nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This retrospective medical record review includes adult patients with incurable cancer who&#xD;
        received parenteral nutrition treatment in palliative care in the time period, January 2011&#xD;
        to December 2017. Only patients who were deceased at point of data abstraction are&#xD;
        included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with incurable cancer&#xD;
&#xD;
          -  Use of parental nutrition in palliative setting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Still alive&#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>Trude Rakel Balstad, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Torstein Baade Rø, md phd</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology, IKOM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arne Solberg, md phd</last_name>
    <role>Study Director</role>
    <affiliation>Cancer Clinic, St. Olavs hospital, Trondheim University hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Telemark</name>
      <address>
        <city>Skien</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset i Vestfold</name>
      <address>
        <city>Tønsberg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parenteral nutrition</keyword>
  <keyword>Medical Records</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Disease Progression</keyword>
  <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/NCT04456647
org study id: 2018/1500
nct id: NCT04456647
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the
      level of evidence for clinical meaningful effects is weak. Guidelines give few specific
      recommendations regarding which patients with incurable cancer that should be offered PN
      treatment. According to the Norwegian prescription database, the use of parenteral nutrition
      has more than doubled in the period 2004-2015. These numbers do not separate between
      diagnoses and medical conditions, so the current use of medical nutrition in cancer patients
      in Norway is not known. The decision to initiate parenteral nutrition is taken at hospitals,
      whereupon the patient returns home to their respective municipalities and receives follow-up
      by the home care service. There are often uncertainties about the duration of treatment, as
      patients' clinical condition can change rapidly. One major challenge health care
      professionals face is to decide when to end medical nutrition therapy. Patients and relatives
      may experience fear that discontinuation of medical nutrition accelerates death, while health
      care professionals often experience that nutrition in many cases does not help and inflicts
      negatively on patients' condition. This makes communication concerning end of nutritional
      treatment between health care professionals at several health care levels, patients and their
      relatives challenging.

      There is a need for a stronger evidence base considering the effect of medical nutrition in
      patients with incurable cancer. To be able to study the effect of PN treatment, more studies
      on clinical practice of PN treatment to patients with incurable cancer is needed. Aspects
      like indication for use, dosage and duration of PN treatment is poorly described in the
      available literature. Thus, the aim of this study is to describe indications for use of PN,
      duration of treatment, reasons for discontinuation, method of administration, possible
      benefits and complications as well as survival.
observational model: Case-Only
time perspective: Retrospective
measure: Received dose of parenteral nutrition
time frame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
description: Dose is measured in kcal/kg/day
measure: Duration of treatment
time frame: From start of parenteral nutrition treatment to termination of parenteral nutrition, up to 3 years
description: Duration is measured in days
measure: Survival
time frame: From start of parenteral nutrition treatment to date of death, up to 7 years
description: Survival is measured in days
measure: Indication for use of parenteral nutrition
time frame: Baseline
description: Registered indication for use of parenteral nutrition treatment
arm group label: Parenteral nutrition
intervention type: Other
intervention name: Parenteral nutrition
description: Parenteral nutrition treatment in palliative care
arm group label: Parenteral nutrition
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Trude Rakel Balstad, phd
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
last name: Torstein Baade Rø, md phd
role: Study Director
affiliation: Norwegian University of Science and Technology, IKOM
last name: Arne Solberg, md phd
role: Study Director
affiliation: Cancer Clinic, St. Olavs hospital, Trondheim University hospital
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor
sharing ipd: No