Lung CancerPhase 2OmegaNCT03936621
Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers
A Phase 2 study testing Omega 3 fatty acid in people with Lung Cancer, run by British Columbia Cancer Agency.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Omega 3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2022
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the detailed description
The table below explains what will be done at each study visit:
Prior to Pre-Registration Informed Consent. Questionnaire (asking about your risks for lung cancer, diet and medications including food supplement). Blood test for CRP level
Prior to Registration/Randomization Blood test for CRP level (about 6 ml or 1 teaspoon) Pregnancy test (either blood or urine, for woman with childbearing potential only)
Registration/Randomization Medical history Physical exam (Vital signs/Body height and weight) Receive 3 month supply of Omega 3 fatty acids for treatment first group. Blood tests for Fasting Blood insulin, etc (about 15 ml or 3 teaspoons) Receive a diary to record the amount of study medication you take each day and any side effects you may experience
Week 2 telephone interview Ask about side effects you may be having Ask about other medications you may be taking Review study agent diary
Month 1 visit (you will not be able to eat anything for 10 hours before the appointment) Blood test for Fasting Blood insulin, etc (15 ml or 3 teaspoons) -( All participants)
Treatment Group:
Ask about side effects you may be having Ask about other medications you may be taking Review study medication diary
Month 2, 4, and 5 telephone interview Review diary Ask about side effects you may be having Ask about other medications you may be taking
Month 3 visit (you will not be able to eat anything for 10 hours before the appointment) Physical exam with vital signs Repeat blood tests (about 15 ml or 3 teaspoons) (All participants)
Treatment Group:
Collect unused omega 3 (for treatment group) Receive next 3 month supply of omega 3 (for treatment group) Review study medication diary Ask about side effects you may be experiencing Ask about other medications you may be taking
Month 6 or end of study visit (if left study early for any reason) Physical exam with vital signs Blood tests (about 15 ml or 3 teaspoons) - All participants
Treatment Group:
Review and collect study agent diary Ask about side effects you may be having Ask about other medications you may be taking
Month 7-12 Cross over study Treatment group will become observation group Observation group will become treatment group with the same procedures in month 1 to 6
- Conditions
- Lung Cancer
- Being tested
- Omega 3 fatty acid
- Keywords
- Omega 3, CRP
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidDrug
Also called EPA, DHA, Omega 3
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Omega 3 fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRP levels in participants from both arms
Blood will be collected over the duration of the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Lam, MD, Principal investigator, BC Cancer Research Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936621
- Sponsor's protocol ID
- H19-00221
- Acronym
- Omega
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
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.
PubMed 36532545
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03936621
- Acronym / sponsor ID
- Omega / H19-00221
- Conditions
- Lung Cancer
- Keywords
- Omega 3, CRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 3 May 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.
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.
Detailed description
The table below explains what will be done at each study visit:
Prior to Pre-Registration Informed Consent. Questionnaire (asking about your risks for lung cancer, diet and medications including food supplement). Blood test for CRP level
Prior to Registration/Randomization Blood test for CRP level (about 6 ml or 1 teaspoon) Pregnancy test (either blood or urine, for woman with childbearing potential only)
Registration/Randomization Medical history Physical exam (Vital signs/Body height and weight) Receive 3 month supply of Omega 3 fatty acids for treatment first group. Blood tests for Fasting Blood insulin, etc (about 15 ml or 3 teaspoons) Receive a diary to record the amount of study medication you take each day and any side effects you may experience
Week 2 telephone interview Ask about side effects you may be having Ask about other medications you may be taking Review study agent diary
Month 1 visit (you will not be able to eat anything for 10 hours before the appointment) Blood test for Fasting Blood insulin, etc (15 ml or 3 teaspoons) -( All participants)
Treatment Group:
Ask about side effects you may be having Ask about other medications you may be taking Review study medication diary
Month 2, 4, and 5 telephone interview Review diary Ask about side effects you may be having Ask about other medications you may be taking
Month 3 visit (you will not be able to eat anything for 10 hours before the appointment) Physical exam with vital signs Repeat blood tests (about 15 ml or 3 teaspoons) (All participants)
Treatment Group:
Collect unused omega 3 (for treatment group) Receive next 3 month supply of omega 3 (for treatment group) Review study medication diary Ask about side effects you may be experiencing Ask about other medications you may be taking
Month 6 or end of study visit (if left study early for any reason) Physical exam with vital signs Blood tests (about 15 ml or 3 teaspoons) - All participants
Treatment Group:
Review and collect study agent diary Ask about side effects you may be having Ask about other medications you may be taking
Month 7-12 Cross over study Treatment group will become observation group Observation group will become treatment group with the same procedures in month 1 to 6
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Omega 3 Fatty Acid | Active comparator | Drug: Omega 3 fatty acidOmega 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. |
| Group 2: Control Arm | Placebo comparator | Drug: Omega 3 fatty acidNo 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 acidAlso: EPA, DHA, Omega 3To 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. | Drug | Group 1: Omega 3 Fatty Acid, Group 2: Control Arm |
Primary outcome
Change in CRP levels in participants from both arms
Time frame: 1 year
Blood will be collected over the duration of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Derived from this study: PubMed 36532545Elisia 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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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.
Stephen Lam, MD principal investigator
BC Cancer Research Ctr
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega 3 fatty acid in people with Lung Cancer, run by British Columbia Cancer Agency.
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 5 inclusion and 4 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Sukhinder Atkar-Khattra, BSc (16046758000 ext. 7095, skhattra@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CRP levels in participants from both arms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936621, which also lists 1 linked publication.
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 7 May 2019.