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

• ClinicalTrials.gov Identifier: NCT03831698
• Recruitment Status: Active, not recruiting
• First Posted: February 6, 2019
• Last Update Posted: November 8, 2022
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): University of Kansas Medical Center

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
Colorectal Cancer; Lynch Syndrome	Drug: Omega-3 fatty acid ethyl esters (2 gram)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 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: February 6, 2019
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: August 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 Name: lovaza

Outcome Measures

Primary Outcome Measures :

1. Retention rate of participants [ Time Frame: 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. [ Time Frame: 12 months ]
   Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0

Eligibility Criteria

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

Criteria

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

United States, Kansas

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

More Information

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03831698
• Other Study ID Numbers: IIT-2018-Omega3-CRC-Prev
• First Posted: February 6, 2019
• Last Update Posted: November 8, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• 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; Disease; Pathologic Processes; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; DNA Repair-Deficiency Disorders; Metabolic Diseases