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Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03831698
Collaborator
(none)
34
Enrollment
1
Location
1
Arm
65.8
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omega-3 fatty acid ethyl esters (2 gram)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)
Actual Study Start Date :
Feb 6, 2019
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Omega-3, 2 grams

Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months

Drug: Omega-3 fatty acid ethyl esters (2 gram)
Omega-3 fatty acid ethyl esters (2 gram)
Other Names:
  • lovaza

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retention rate of participants [12 months]

      Feasibility is defined as at least 80% retention rate

    Secondary Outcome Measures

    1. Proportion of participants with treatment-related adverse events in each arm. [12 months]

      Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent

    • Candidate for elective endoscopy procedure

    • Participants with known Lynch Syndrome

    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

    • Willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and biopsy at 12 months visit.

    • Participants taking Aspirin for chemoprevention must agree to stop it for at least 4 weeks prior to study entry and throughout the trial period

    • Adequate organ and marrow function

    • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.

    • Men of child-bearing potential must not father a child or donate sperm while on this study and for 90 days after their last study treatment.

    Exclusion Criteria:

    • Current or anticipated use of other investigational agents while participating in this study.

    • Psychiatric illness/social situations that could limit compliance with study requirements.

    • Pregnant or breast feeding.

    • Familial adenomatous polyposis, Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.

    • Previous or known active malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for more than 5 years

    • Current use of anticoagulation therapy

    • Current use of therapeutic doses of aspirin for reasons other than chemoprevention

    • Use of omega 3 fatty acids or flaxseed supplements within 4 weeks before this study's screening/baseline colonoscopy

    • Use of high dose omega 3 fatty acids within the past 3 months prior to study baseline/screening

    • Current, regular use of non-steroidal anti-inflammatory drugs (NSAIDS)

    • Allergy to fish and/or fish products

    • Uncontrolled infectious disease

    • Malabsorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.

    • Unable to swallow and retain oral medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Kansas Cancer Center, Westwood Campus Kansas City Kansas United States 66205

    Sponsors and Collaborators

    • University of Kansas Medical Center

    Investigators

    • Principal Investigator: Anwaar Saeed, MD, The University of Kansas Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT03831698
    Other Study ID Numbers:
    • IIT-2018-Omega3-CRC-Prev
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Kansas Medical Center
    Omega 3
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Colorectal Neoplasms, Hereditary Nonpolyposis
    Syndrome

    Study Results

    No Results Posted as of Jun 8, 2022