Moffitt Cancer Center: Clinical Trial 19622

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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

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 who has a diagnosis of a Lung RADS 3

History of cigarette smoking with ≥ 30 pack years

Quit smoking ≥ 3 months (Negative cotinine by urine dipstick)

Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1

Able to swallow study pills

Able to undergo Low Dose Computer Tomography (LDCT)

Not allergic to components of study agents

Willing to participate in smoking cessation maintenance program if relapse occurs

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

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

Prior history of cancer (except non-melanoma of skin) or other co-existing cancers

Significant co-morbid disease

Hypoxemia with the required use of supplemental oxygen

Use of inhaled steroids within 6 weeks of trial enrollment

Presence of 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).