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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831698
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
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 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831698


Contacts
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Contact: CT Nurse Navigator 913-945-7552 ctnursenav@kumc.edu

Locations
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United States, Kansas
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: Clinical Trials Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Anwaar Saeed, MD The University of Kansas Cancer Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03831698     History of Changes
Other Study ID Numbers: IIT-2018-Omega3-CRC-Prev
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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