Clinical trial NCT03936621: Efficacy and Safety of Omega 3 Fatty Acid Supplements on Heavy Smokers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Keywords: Omega 3
CRP
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Lotte & John Hecht Memorial Foundation
First posted: 2019-05-03
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SCREENING

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.

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

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

Primary outcomes:
measure: Change in CRP levels in participants from both arms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BC Cancer Research Ctr
name: Stephen Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: