Omega-3 Supplements for Lynch Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byAnwaar Saeed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Lynch Syndrome.

I agree to stop taking Aspirin for 4 weeks before and during the trial.

I am willing to have two colonoscopies and biopsies, one now and another in a year.

+6 more

Exclusion Criteria

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

I am currently on blood thinners.

I haven't taken omega 3 or flaxseed supplements in the last 4 weeks.

+11 more

Participant Groups

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.

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