Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers (NCT03936621) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers
42 participantsStarted 2019-06-01
Plain-language summary
The study duration is 12 months. The initial enrollment visit will take approximately one hour. The Month 1, 3, 6, 7, 9 and 12 visits will take approximately 30 minutes each. The three telephone visits will take approximately 10 minutes each. The total time commitment to the study will be approximately four and a half hours.
Who can participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are between the ages of 55 and 80 years
* Are a current or former smoker with a 30 pack-year (e.g. one pack of cigarettes a day for 30 years) smoking history or
* Have a greater than 1.51% chance of developing lung cancer in the next six years based on the investigator's risk prediction tool
* Have elevation of a marker of inflammation called C-Reactive Protein (CRP)
* Are capable of providing informed consent to participate in the study
Exclusion Criteria:
* Have been previously diagnosed with lung cancer
* Have had other non-curatively treated cancer outside the lung.
* Have any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize your safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-existing illnesses
* Are currently taking omega 3 fatty acid supplements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in CRP levels in participants from both arms