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

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

Clinicaltrials.gov identifier:
NCT03831698

Prevention:
Colorectal

Study Contact Information:

Contact: Clinical Trials Nurse Navigator by phone: 913-945-7552 or by email.    


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

About the Study

This study looks at how well omega-3 fatty acid ethyl esters (generic Lovaza) work in preventing colorectal cancer in patients with Lynch syndrome. Omega-3 fatty acids work by decreasing inflammation, or swelling, in the body, and suppressing certain chemicals in the body that are known to cause cancer. The addition of omega-3 fatty acids to patients' diets may help decrease colon inflammation or suppress cancer-causing chemicals in the body.

Type of Study

This Phase 2 study will be a single arm, open label study. All participants in this study will receive the same intervention, and both the researchers and the participants will know about the treatment being administered.

What the Study Entails

  • Participants will undergo a colonoscopy and biopsy at baseline at the start of the study. 
  • Each study participant will receive 2 grams of Omega-3 fatty acid ethyl esters orally (by mouth) once per day for 12 months.
  • Study participants will be followed for 12 months.
  • Study participants will undergo another colonoscopy and biopsy at their 12 month visit.

Study Site

Kansas City, Kansas
The University of Kansas Cancer Center, Westwood Campus
Contact: Clinical Trials Nurse Navigator by phone: 913-945-7552 or by email.             

 

 

This Study is Open To:

Men and women age 18 years or older can be considered for enrollment in this study if they:

  • Have Lynch Syndrome
  • Are willing to undergo a colonoscopy and biopsy at baseline and another colonoscopy and biopsy at 12 months visit
  • Are a candidate for elective endoscopy procedure
This Study is Not Open To:

People with the following are not eligible:

  • Familial adenomatous polyposis, Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
  • Previous or known active malignancies (except non-melanoma skin cancer) unless curatively treated and with no evidence of recurrence for more than 5 years
  • Current use of anticoagulation therapy (blood thinners)
  • Current use of therapeutic doses of aspirin for reasons other than chemoprevention
  • Current, regular use of non-steroidal anti-inflammatory drugs (NSAIDS)
  • An allergy to fish and/or fish products