Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers (Omega)
Lung Cancer
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Omega 3, CRP
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Group 1: Omega 3 Fatty Acid
Group 2: Control Arm
Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. In the first 6 months, you will be asked to take one capsule of Omega 3 fatty acids with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks. In the next 6 months (Months 7 to 12), you will have a blood test for markers of inflammation at the end of Month 7 and at Month 9 and 12 to determine if the anti-inflammatory effects of Omega 3 acids are still there after you have stopped taking it.
No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months. You will be asked to have a blood test for markers of inflammation at Month 1, 3 and 6 for markers of inflammation to determine the natural variation of the levels of these markers without Omega 3 fatty acid supplements. In Month 7, you will be asked to take one capsule of Omega 3 with breakfast and 1 with dinner/day for the first week, 2 capsules in the morning and one capsule in the evening for the second week and then 2 capsules with breakfast and 2 with dinner/day for the remaining 24 weeks.