Clinical Trial 19622

• Overview

  Study Title:

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

  Summary:

  Evaluate the effectiveness of Curcumin C3 complex® combined with Lovaza® at 2 dose arms vs. placebo for 6 months to asymptomatic former and current 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.

• Treatments

  Therapies:

  Observational; Therapy (NOS)

  Medications:

  Curcumin C3 (); Lovaza (); Placebo ()

• Inclusion Criteria

  • Male or female, 55 years of age or older
  • Former smokers and current enrolled in LDCT lung cancer screening or those who are detected using a regular CT, and have Lung-RADS 3 category lesion(s), that would get a 6 month f/u LDCT or regular CT based on Lung-RADS recommendations or former and current smokers enrolled in LDCT lung cancer screening, or regular CT and have Lung-RADS 2 category lesions with part-solid or non-solid lung nodule >4mm mean diameter detected during screening LDCT or regular CT scans
  • History of cigarette smoking > 20 pack years
  • All current smokers should accept to receive smoking cessation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 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 containing components of study agents. 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
  • Participants must have normal organ and marrow function
  • 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

  • History of lung cancer or invasive malignancy (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
  • Inability to undergo CT
  • Newly diagnosed nodule meeting Lung-RADS 4 criteria
  • Have taken doxycycline or tetracycline less than or equal to 2 weeks
  • Females- pregnant or lactating (throughout the duration of intervention of 6 months)
  • Unwilling to use effective form of birth control (Males and females) (throughout the duration of intervention of 6 months).

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