Fish Oil and Curcumin in Preventing Lung Nodules from Growing Larger in Former and Current Smokers

Status: closed to accrual

This phase II trial studies how well fish oil and curcumin work in preventing lung nodules from growing larger in former and current smokers. Fish oil may work by decreasing the amount of triglycerides and other fats made in the liver. Curcumin is extracted from turmeric root and has antioxidant and anti-inflammatory properties. Giving fish oil and curcumin may help prevent lung nodules from growing larger in former and current smokers.

Inclusion Criteria

Male or female, 55 years of age or older including the following groups of subjects: * 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 lung nodule >= 4mm mean diameter detected during screening LDCT or regular CT scan.
History of cigarette smoking with >= 20 pack years.
All current smokers should be offered smoking cessation services.
Eastern Cooperative Oncology Group (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 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.
Complete blood count (CBC)- no clinically significant findings.
Complete metabolic panel (CMP)- no clinically significant findings.
PT/PTT- within normal institutional limits (10.2-12.9 sec)/(2.0-3.0).
LDH- equal to or below the upper limit of normal (135-225 u/l).
Serum creatinine < 1.5 mg/dl or measured creatinine clearance 60 cc/min.
Negative urine human chorionic gonadotropin (HCG) (females-premenopausal).
Willing to use contraception during the intervention period of 6 months (males and pre-menopausal females).
Not pregnant or lactating nor planning to become pregnant or lactate (pre-menopausal women) during the 6 month study intervention period.

Exclusion Criteria

History of lung cancer or other invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma).
Inability to undergo CT.
Newly diagnosed nodule meeting Lung-RADS 4 criteria.
Have taken doxycycline or tetracycline =< 2 weeks.

PRIMARY OBJECTIVES:

I. Effectiveness of the combination of curcumin/demethoxycurcumin/bisdemethoxy curcumin-containing supplement (Curcumin C3 complex) + Lovaza (omega-3-acid ethyl esters) at 2 dose arms versus (vs.) placebo for 6 months to asymptomatic former and current smokers with lung nodules (high risk cohort screened and followed using low dose computed tomography [LDCT] or by using standard computed tomography [CT]), as indicated by:

Ia. Change in size of CT-detected lung nodules.

Ib. Number of nodules >= 4 mm, and lung nodule density between the treatment and placebo arms.

SECONDARY OBJECTIVES:

I. Safety of the combined agents (Curcumin C3 complex + Lovaza [omega-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 markers (complete blood count [CBC] & complete metabolic profile [CMP], lactate dehydrogenase [LDH], prothrombin time [PT]/partial thromboplastin time [PTT]) at baseline, midpoint, and end of intervention.

II. Bioavailability of the combination agents in the 2 dose arms vs. placebo, we will measure change in curcumin and its metabolites in plasma as well as plasma n-3 Index at baseline, midpoint, and at the end of treatment.

III. 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.

IV. Effect of the combination agents (Curcumin C3 complex + Lovaza [omega-3-acid ethyl esters]) at the 2 dose arms vs. placebo as indicated by modulation of other intermediate endpoint biomarkers (IEBs) including: (a) inflammation- associated chemokines and cytokines (b) pro-resolving lipid mediators (c) targeted pathways NF-kappaB and (d) correlation of these findings with modulation of size of lung nodules.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP A: Patients receive omega-3-acid ethyl esters orally (PO) twice daily (BID) and Curcumin C3 complex PO BID for 6 months.

GROUP B: Patients receive omega-3-acid ethyl esters PO BID, Curcumin C3 complex PO BID, and placebo PO BID for 6 months.

GROUP C: Patients receive placebo PO BID for 6 months.

After completion of study, patients are followed up at 7 days.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Fish Oil and Curcumin in Preventing Lung Nodules from Growing Larger in Former and Current Smokers

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help