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Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former Smokers
We will provide combination of Curcumin C3 complex (8,000 mgs or 4,000 mgs) + Lovaza (4 grams or 2 grams) (w-3 -Acid Ethyl Esters) administered in 2 dose arms vs. placebo for 6 months to asymptomatic former smokers with lung nodules detected during LDCT screening (Lung-RADS 3) and evaluate: 2.1 Primary Objectives Effectiveness of the combination of Curcumin C3 complex + Lovaza (w-3 -Acid Ethyl Esters) at 2 dose arms vs. placebo for 6 months to asymptomatic former smokers with lung nodules detected during LDCT screening (Lung-RADS 3) as indicated by: (a) Change in size of CT-detected lung nodules. (b) Number of nodules¡Ý4 mm, and lung nodule density of partially solid and non-solid Lung-RADS 3 nodules between the treatment and placebo arms. 2.2 Secondary Objectives Safety of the combined agents (Curcumin C3 complex +Lovaza (w-3 -Acid Ethyl Esters) at these 2 dose arms vs. Placebo as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, Safety Lab (CBC & CMP) at baseline, midpoint, and end of intervention. 2.2.1 Bioavailability of the combination agents in the 2 dose arms vs. Placebo, we will measure change in curcumin and its metabolites in plasma and urine as well as plasma n-3 Index at baseline, midpoint, and at the end of intervention. 2.2.2 Adherence and acceptability of the combination agents at the 2 dose arms vs. Placebo, we will conduct pill counts, collect diet and pill logs at baseline, midpoint and at the end of intervention. 2.2.3 Effect of the combination agents (Curcumin C3 complex + Lovaza (w-3 -Acid Ethyl Esters) at the 2 dose arms vs. Placebo as indicated by modulation of other IEBs including: (a) inflammation- associated chemokines and cytokines; (b) pro-resolving lipid mediators; (c) targeted pathways NF-kB and the (d) correlation of these findings with modulation of size of lung nodules.