Clinical trial · Interventional

Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers

A Phase II Randomized Cross-over Study of the Efficacy and Safety of Omega 3 Fatty Acid Supplements on Lung Cancer-Promoting Inflammatory Markers in Heavy Smokers

NCT03936621CI-TRIAL-00038503OmegaunknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Omega 3 fatty acid	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Group 1: Omega 3 Fatty Acid
description
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.
interventionNames
1. Drug: Omega 3 fatty acid
type
PLACEBO_COMPARATOR
label
Group 2: Control Arm
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 55 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDElisia I, Yeung M, Kowalski S, Wong J, Rafiei H, Dyer RA, Atkar-Khattra S, Lam S, Krystal G. Omega 3 supplementation reduces C-reactive protein, prostaglandin E2 and the granulocyte/lymphocyte ratio in heavy smokers: An open-label randomized crossover trial. Front Nutr. 2022 Dec 1;9:1051418. doi: 10.3389/fnut.2022.1051418. eCollection 2022. PMID 36532545