<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/NCT03751384</url>
  </required_header>
  <id_info>
    <org_study_id>H-15000693</org_study_id>
    <nct_id>NCT03751384</nct_id>
  </id_info>
  <brief_title>Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer</brief_title>
  <official_title>Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <brief_summary>
    <textblock>
      Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia.&#xD;
      However, compliance is generally low. This case control study is conducted in order to&#xD;
      investigate if compliance depends upon the physical properties of the supplement (capsules&#xD;
      vs. drinks). In order to further investigate how compliance can be improved, a possible&#xD;
      correlation between sideeffects and rate of increased polyunsaturated fatty acid&#xD;
      concentration in blood is also tested&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an&#xD;
      oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same&#xD;
      in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment&#xD;
      was the primary outcome. Blood concentrations of EPA secondary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2015</start_date>
  <completion_date type="Actual">November 10, 2018</completion_date>
  <primary_completion_date type="Actual">September 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Allocation, not randomized</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>pseudo-anonymized</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of Capsules and bottles counted</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte concentration of EPA</measure>
    <time_frame>4 weeks</time_frame>
    <description>Concentration measured on isolated erythrocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Compliance</condition>
  <condition>Abdominal Cancer</condition>
  <arm_group>
    <arm_group_label>Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary Supplement: Möllers Omega-3 Ekstra Sterk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement: Nutrifriend Cachexia</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Möllers Omega-3 Ekstra Sterk</intervention_name>
    <arm_group_label>Capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrifriend Cachexia</intervention_name>
    <arm_group_label>Drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer&#xD;
&#xD;
          -  Not terminally ill&#xD;
&#xD;
          -  Subjects must be18 years of age (or older)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not read/speak/understand Danish&#xD;
&#xD;
          -  Familial hypercholesterolemia&#xD;
&#xD;
          -  Predialytic patients (GFR &lt; 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L)&#xD;
&#xD;
          -  Use of blood thinners&#xD;
&#xD;
          -  Bleeder's disease&#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>Jens R Andersen</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 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>Associated Professor</investigator_title>
  </responsible_party>
  <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/NCT03751384
org study id: H-15000693
nct id: NCT03751384
lead sponsor: 
collaborator: 
Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia.
      However, compliance is generally low. This case control study is conducted in order to
      investigate if compliance depends upon the physical properties of the supplement (capsules
      vs. drinks). In order to further investigate how compliance can be improved, a possible
      correlation between sideeffects and rate of increased polyunsaturated fatty acid
      concentration in blood is also tested
Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an
      oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same
      in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment
      was the primary outcome. Blood concentrations of EPA secondary.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Allocation, not randomized
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: pseudo-anonymized
measure: Compliance
time frame: 4 weeks
description: Number of Capsules and bottles counted
measure: Erythrocyte concentration of EPA
time frame: 4 weeks
description: Concentration measured on isolated erythrocytes
arm group label: Capsules
arm group type: Experimental
description: Dietary Supplement: Möllers Omega-3 Ekstra Sterk
arm group label: Drink
arm group type: Active Comparator
description: Dietary Supplement: Nutrifriend Cachexia
intervention type: Dietary Supplement
intervention name: Möllers Omega-3 Ekstra Sterk
arm group label: Capsules
intervention type: Dietary Supplement
intervention name: Nutrifriend Cachexia
arm group label: Drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens R Andersen
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Associated Professor
sharing ipd: No