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Omega-3 Fatty Acids

Omega-3 Supplements for Lynch Syndrome

Phase 2
Waitlist Available
Led By Anwaar Saeed, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with known Lynch Syndrome
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Must not have
Current use of anticoagulation therapy
Current use of therapeutic doses of aspirin for reasons other than chemoprevention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of a fish oil supplement on changes in the gut microbiome of people at high risk for colorectal cancer.

Who is the study for?
This trial is for people with Lynch Syndrome, a condition increasing colorectal cancer risk. They must be in good physical shape (ECOG 0-1), not on high-dose omega-3s or NSAIDs recently, and willing to stop aspirin if taking it for prevention. Participants need functioning organs and marrow, agree to two colonoscopies/biopsies, and use strict contraception if of child-bearing potential.
What is being tested?
The study tests the effects of moderate dose omega-3-acid ethyl esters capsules on molecular changes and gut bacteria in those at high risk for colorectal cancer. It's an open-label pilot study where all participants receive the same treatment without a comparison group.
What are the potential side effects?
While specific side effects are not listed here, omega-3 fatty acids can sometimes cause digestive issues like nausea or diarrhea, fishy aftertaste, bleeding tendencies due to blood thinning effect, or allergic reactions especially in those with fish allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Lynch Syndrome.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on blood thinners.
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I am currently taking aspirin for reasons other than cancer prevention.
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I regularly take NSAIDs for pain or inflammation.
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I cannot swallow or keep down pills.
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I have a condition that affects how my stomach or intestines absorb food, or I've had surgery on these organs.
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I have a genetic condition or inflammatory bowel disease.
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I do not have any uncontrolled infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Retention rate of participants
Secondary study objectives
Proportion of participants with treatment-related adverse events in each arm.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Omega-3, 2 gramsExperimental Treatment1 Intervention
Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,874 Total Patients Enrolled
Anwaar Saeed, MDPrincipal InvestigatorThe University of Kansas Cancer Center
4 Previous Clinical Trials
308 Total Patients Enrolled

Media Library

Omega-3 fatty acid ethyl esters (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT03831698 — Phase 2
Colorectal Cancer Research Study Groups: Omega-3, 2 grams
Colorectal Cancer Clinical Trial 2023: Omega-3 fatty acid ethyl esters Highlights & Side Effects. Trial Name: NCT03831698 — Phase 2
Omega-3 fatty acid ethyl esters (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03831698 — Phase 2
~3 spots leftby Nov 2025
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