Colorectal CancerPhase 2NCT03831698
Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)
A Phase 2 study testing Omega-3 fatty acid ethyl esters (2 gram) in people with Colorectal Cancer and Lynch Syndrome, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lynch Syndrome
- What is being tested?
- Omega-3 fatty acid ethyl esters (2 gram)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
About this study
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.
- Conditions
- Colorectal Cancer, Lynch Syndrome
- Being tested
- Omega-3 fatty acid ethyl esters (2 gram)
- Keywords
- Omega 3
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid ethyl esters (2 gram)Drug
Also called lovaza
Omega-3 fatty acid ethyl esters (2 gram)
| Study group | Role | What they receive |
|---|---|---|
| Omega-3, 2 grams | Experimental | Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months Receives: Drug: Omega-3 fatty acid ethyl esters (2 gram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of participants
Feasibility is defined as at least 80% retention rate
Measured: 12 months
Secondary outcomes (1)
Proportion of participants with treatment-related adverse events in each arm.
Measured by Common Terminology Criteria Adverse Events (CTCAE) V5.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start6 Feb 2019
- Primary completion8 Jun 2022
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anwaar Saeed, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831698
- Sponsor's protocol ID
- IIT-2018-Omega3-CRC-Prev
- Status last verified
- May 2023
- First submitted
- 4 Feb 2019
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega 3 Fatty Acids in Colorectal Cancer (CRC) Prevention in Patients With Lynch Syndrome (COLYNE)
- ClinicalTrials.gov ID
- NCT03831698
- Acronym / sponsor ID
- IIT-2018-Omega3-CRC-Prev
- Conditions
- Colorectal Cancer, Lynch Syndrome
- Keywords
- Omega 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3, 2 grams | Experimental | Drug: Omega-3 fatty acid ethyl esters (2 gram)Omega-3 fatty acid ethyl esters (2 grams) orally (by mouth) once per day for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid ethyl esters (2 gram)Also: lovazaOmega-3 fatty acid ethyl esters (2 gram) | Drug | Omega-3, 2 grams |
Primary outcome
Retention rate of participants
Time frame: 12 months
Feasibility is defined as at least 80% retention rate
1 secondary outcome
Proportion of participants with treatment-related adverse events in each arm.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwaar Saeed, MD principal investigator
The University of Kansas Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 fatty acid ethyl esters (2 gram) in people with Colorectal Cancer and Lynch Syndrome, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate of participants (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.