<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/NCT02980289</url>
  </required_header>
  <id_info>
    <org_study_id>DANSAC-EPI</org_study_id>
    <nct_id>NCT02980289</nct_id>
  </id_info>
  <brief_title>DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Signe Harder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to investigate the prevalence and treatment of nausea and/or vomiting in&#xD;
      patients with advanced cancer not receiving chemotherapy or irradiation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week</measure>
    <time_frame>From baseline and at 1 week (5-9 days)</time_frame>
    <description>The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week</measure>
    <time_frame>1 week (5-9 days)</time_frame>
    <description>Change in nausea CAT-score from baseline to 24 hours and 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea at screening from EORTC-QLQ-C15-Pal at baseline</measure>
    <time_frame>At baseline</time_frame>
    <description>Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emesis at screening from EORTC-QLQ-C15-Pal at baseline</measure>
    <time_frame>At baseline</time_frame>
    <description>Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week</measure>
    <time_frame>From baseline and at 1 week (5-9 days)</time_frame>
    <description>Change in other parameters potentially indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">821</enrollment>
  <condition>Advanced Cancer</condition>
  <condition>Nausea</condition>
  <condition>Emesis</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients over 18 years old with advanced cancer defined as metastatic disease, no curable treatment options. The patients may not have received chemotherapy or irradiation within 4 weeks, no operations within 2 weeks and no general anesthesia within 4 days.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4&#xD;
        weeks prior to screening, will be screened for nausea and/or vomiting following evaluation&#xD;
        of the primary inclusion-/exclusion criteria. The patients can be located either in the&#xD;
        hospital departments, at home or in a hospice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Advanced cancer&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Ability to read and understand the forms required for the study&#xD;
&#xD;
          4. Life-expectancy more than 2 weeks.&#xD;
&#xD;
          5. Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Surgery to the brain or abdomen within the last 2 weeks or exposure to general&#xD;
             anesthesia within the last 4 days.&#xD;
&#xD;
          2. Chemotherapy or radiation therapy within the last 4 weeks&#xD;
&#xD;
          3. Symptoms of increased intracranial pressure or cerebral metastasis. If this is&#xD;
             suspected, a normal MRI scan of the cerebrum is needed before inclusion&#xD;
&#xD;
          4. Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study&#xD;
             Investigator&#xD;
&#xD;
          5. Pregnancy&#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>Odense Universityhospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>March 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Signe Harder</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</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/NCT02980289
org study id: DANSAC-EPI
nct id: NCT02980289
lead sponsor: 
has dmc: No
The study aims to investigate the prevalence and treatment of nausea and/or vomiting in
      patients with advanced cancer not receiving chemotherapy or irradiation.
observational model: Cohort
time perspective: Prospective
measure: 2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
time frame: From baseline and at 1 week (5-9 days)
description: The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours.
measure: Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week
time frame: 1 week (5-9 days)
description: Change in nausea CAT-score from baseline to 24 hours and 7 days
measure: Nausea at screening from EORTC-QLQ-C15-Pal at baseline
time frame: At baseline
description: Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender
measure: Emesis at screening from EORTC-QLQ-C15-Pal at baseline
time frame: At baseline
description: Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender
measure: Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week
time frame: From baseline and at 1 week (5-9 days)
description: Change in other parameters potentially indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life
arm group label: Patients
description: Patients over 18 years old with advanced cancer defined as metastatic disease, no curable treatment options. The patients may not have received chemotherapy or irradiation within 4 weeks, no operations within 2 weeks and no general anesthesia within 4 days.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: Signe Harder
investigator title: Doctor
mesh term: Nausea
sharing ipd: No