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| Name | Class |
|---|---|
| Lotte & John Hecht Memorial Foundation | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CRP levels in participants from both arms | Blood will be collected over the duration of the study | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukhinder Atkar-Khattra, BSc | Contact | 16046758000 | 7095 | skhattra@bccancer.bc.ca |
| Anne DyBuncio, BSc | Contact | 604-675-8089 | adybuncio@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Lam, MD | BC Cancer Research Ctr | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36532545 | Derived | 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. |
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Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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.
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A computer will be used to select participants for each of the study groups.
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |