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Clinical Trial 19622

Cancer Type: Thoracic
Interventions:Curcumin C3; Lovaza; Placebo

Study Type: Prevention
Phase of Study: Phase II
Investigators:

  • Nagi Kumar

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former Smokers

Summary

Evaluate the effectiveness of Curcumin C3 complex® combined with Lovaza® (ω-3 -Acid Ethyl Esters) at 2 dose arms vs. placebo for 6 months to asymptomatic former smokers with lung nodules detected during LDCT or standard CT screening

Objective

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.

Inclusion Criteria

  • Male or female, 55 years of age or older including the following groups of subjects: Group 1, former smokers enrolled in LDCT lung cancer screening, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT based on Lung-RADS recommendations. Group 2, former smokers with lung cancer > 2 yrs ago, with subsolid nodule(s) that is/are slowly growing (> 6 mm total diameter), or stable on CT for 10 mm, or part solid nodule > 8 mm). Group 3, former smokers without history of lung cancer, and nodule requirements the same as Group 2. Group 4 former smokers with lung cancer > 2 yrs ago, who have one or more subsolid nodules with CT, characteristics and patient risk factors such that their lung cancer expert clinician deems that they need a follow up CT in 6 months
  • History of cigarette smoking with ≥ 20 pack years
  • All current smokers should accept to receive smoking cessation
  • ECOG performance score of ≤ 1.
  • Able to swallow study pills
  • Able to undergo CT
  • Not allergic to components of study agents
  • Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study
  • Willing to comply with proposed visit and treatment schedule
  • Able to understand and willing to sign a written informed consent document
  • Subjects with stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is completed at least 24 months prior to randomization.
  • Participants must have normal organ and marrow function as defined per protocol.
  • Willing to use contraception during the intervention period of 6 months (males and females)
  • Not pregnant or lactating nor planning to become pregnant or lactate during the 6 month study intervention period

  • Exclusion Criteria

  • Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization;
  • Inability to undergo CT
  • Newly diagnosed nodule meeting Lung-RADS 4 criteria (Table 2)
  • Have taken doxycycline or tetracycline ≤ 2 weeks
  • Additional exclusions may apply