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

NCT03936621 | Unknown Phase 2

• 1 other identifier: H19-00221
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Cancer

Keywords

Omega 3; CRP

Outcome Measures

Primary Outcomes (1)

• Change in CRP levels in participants from both arms

  Blood will be collected over the duration of the study

  1 year

Study Arms (2)

Group 1: Omega 3 Fatty Acid

ACTIVE COMPARATOR

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.

Drug: Omega 3 fatty acid

Group 2: Control Arm

PLACEBO COMPARATOR

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.

Drug: Omega 3 fatty acid

Interventions

Omega 3 fatty acid DRUG

To evaluate the efficacy of 3.6 g omega 3 fatty acid supplements (2.4 g EPA + 1.2 g DHA)/day for 6 months versus no treatment at reducing the level of C-reactive protein (CRP) in ever smokers at high risk of lung cancer. The primary endpoint of the study is reduction of CRP.

Also known as: EPA, DHA, Omega 3

Group 1: Omega 3 Fatty Acid; Group 2: Control Arm

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Lotte & John Hecht Memorial Foundation: collaborator

Related Publications (1)

• Elisia 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 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Stephen Lam, MD

  BC Cancer Research Ctr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukhinder Atkar-Khattra, BSc

CONTACT

16046758000; skhattra@bccancer.bc.ca

Anne DyBuncio, BSc

CONTACT

604-675-8089; adybuncio@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A computer will be used to select participants for each of the study groups.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants are randomized into 2 study groups. Group 1 Omega 3 fatty acids for 6 months and then off omega 3 fatty acids for the next 6 months. Group 2. No Omega 3 fatty acids for the first 6 months followed by Omega 3 fatty acids for the next 6 months.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 3, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share