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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Lynch Syndrome
• Intervention / Treatment: Drug: Omega-3 fatty acid ethyl esters (2 gram)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Westwood Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate of participants	Feasibility is defined as at least 80% retention rate	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with treatment-related adverse events in each arm.	Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): June 8, 2022
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Omega 3
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Syndrome; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: IIT-2018-Omega3-CRC-Prev

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No