<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/NCT03831698</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2018-Omega3-CRC-Prev</org_study_id>
    <nct_id>NCT03831698</nct_id>
  </id_info>
  <brief_title>Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)</brief_title>
  <official_title>Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl&#xD;
      esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in&#xD;
      participants at high risk for colorectal cancer. The study will be a single arm, open label&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Actual">June 8, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention rate of participants</measure>
    <time_frame>12 months</time_frame>
    <description>Feasibility is defined as at least 80% retention rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with treatment-related adverse events in each arm.</measure>
    <time_frame>12 months</time_frame>
    <description>Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Lynch Syndrome</condition>
  <arm_group>
    <arm_group_label>Omega-3, 2 grams</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega-3 fatty acid ethyl esters (2 gram)</intervention_name>
    <description>Omega-3 fatty acid ethyl esters (2 gram)</description>
    <arm_group_label>Omega-3, 2 grams</arm_group_label>
    <other_name>lovaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability of participant or Legally Authorized Representative (LAR) to understand this&#xD;
             study, and participant or LAR willingness to sign a written informed consent&#xD;
&#xD;
          -  Candidate for elective endoscopy procedure&#xD;
&#xD;
          -  Participants with known Lynch Syndrome&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1&#xD;
&#xD;
          -  Willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and&#xD;
             biopsy at 12 months visit.&#xD;
&#xD;
          -  Participants taking Aspirin for chemoprevention must agree to stop it for at least 4&#xD;
             weeks prior to study entry and throughout the trial period&#xD;
&#xD;
          -  Adequate organ and marrow function&#xD;
&#xD;
          -  Women of child-bearing potential and men with partners of child-bearing potential must&#xD;
             agree to practice sexual abstinence, or to use two forms of adequate contraception&#xD;
             (hormonal AND barrier method of birth control) prior to study entry, for the duration&#xD;
             of study participation, and for 90 days following completion of therapy. If a woman&#xD;
             becomes pregnant or suspects she is pregnant while participating in this study, she&#xD;
             should inform her treating physician immediately.&#xD;
&#xD;
          -  Men of child-bearing potential must not father a child or donate sperm while on this&#xD;
             study and for 90 days after their last study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or anticipated use of other investigational agents while participating in this&#xD;
             study.&#xD;
&#xD;
          -  Psychiatric illness/social situations that could limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Pregnant or breast feeding.&#xD;
&#xD;
          -  Familial adenomatous polyposis, Putz-Jeghers disease, ulcerative colitis, or Crohn's&#xD;
             disease.&#xD;
&#xD;
          -  Previous or known active malignancies, except non-melanoma skin cancers, unless&#xD;
             curatively treated and with no evidence of recurrence for more than 5 years&#xD;
&#xD;
          -  Current use of anticoagulation therapy&#xD;
&#xD;
          -  Current use of therapeutic doses of aspirin for reasons other than chemoprevention&#xD;
&#xD;
          -  Use of omega 3 fatty acids or flaxseed supplements within 4 weeks before this study's&#xD;
             screening/baseline colonoscopy&#xD;
&#xD;
          -  Use of high dose omega 3 fatty acids within the past 3 months prior to study&#xD;
             baseline/screening&#xD;
&#xD;
          -  Current, regular use of non-steroidal anti-inflammatory drugs (NSAIDS)&#xD;
&#xD;
          -  Allergy to fish and/or fish products&#xD;
&#xD;
          -  Uncontrolled infectious disease&#xD;
&#xD;
          -  Malabsorption syndrome, disease affecting gastrointestinal function, or previous&#xD;
             resection of the stomach or small bowel.&#xD;
&#xD;
          -  Unable to swallow and retain oral medication&#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>Anwaar Saeed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Kansas Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center, Westwood Campus</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Omega 3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Syndrome</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/NCT03831698
org study id: IIT-2018-Omega3-CRC-Prev
nct id: NCT03831698
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a pilot study aimed at assessing the effects of moderate dose omega-3-acid ethyl
      esters capsules (generic Lovaza) on molecular, and intestinal microbiota changes in
      participants at high risk for colorectal cancer. The study will be a single arm, open label
      study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retention rate of participants
time frame: 12 months
description: Feasibility is defined as at least 80% retention rate
measure: Proportion of participants with treatment-related adverse events in each arm.
time frame: 12 months
description: Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0
arm group label: Omega-3, 2 grams
arm group type: Experimental
description: Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months
intervention type: Drug
intervention name: Omega-3 fatty acid ethyl esters (2 gram)
description: Omega-3 fatty acid ethyl esters (2 gram)
arm group label: Omega-3, 2 grams
other name: lovaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anwaar Saeed, MD
role: Principal Investigator
affiliation: The University of Kansas Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Syndrome
sharing ipd: No