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Lovaza + Curcumin for Lung Nodule Reduction

Phase 2

Recruiting

Led By Nagi Kumar, Ph.D

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have normal organ and marrow function

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post treatment

Summary

This trial will test if Lovaza + Curcumin C3 Complex can help reduce the size of lung nodules and if it is safe to take.

Who is the study for?

This trial is for current or former smokers aged 55+ with a history of heavy smoking (≥20 pack years), who have certain types of lung nodules detected on CT scans. Participants must be able to swallow pills, undergo CT scans, and willing to stop taking any vitamin/mineral supplements that overlap with the study drugs.

What is being tested?

Researchers are testing if Lovaza (fish oil) combined with Curcumin C3 Complex can reduce the size of lung nodules in smokers. The safety and tolerability of this drug combination are also being evaluated in this phase II trial.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions to Lovaza and Curcumin C3 Complex. These could include typical supplement-related issues such as digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are functioning normally.

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I am fully active or can carry out light work.

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I am 55 years old or older.

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I have smoked at least 20 pack-years.

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I am a smoker and agree to start a smoking cessation program.

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I am willing to stop taking my current vitamins for the study's provided supplement.

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I can have a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am willing to use effective birth control for 6 months.

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I cannot have a CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Bronchial Nodule Size

Rate of Nodules ≥4 mm

Secondary study objectives

Rate of Adherence

Rate of Treatment Related Adverse Events (AEs)

Trial Design

3Treatment groups

Active Control

Group I: Curcumin C3 complex® +Lovaza® +PlaceboActive Control3 Interventions

Group B: 2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM. 1 placebo capsule twice a day, AM and PM.

Group II: Curcumin C3 complex® +Lovaza®Active Control2 Interventions

Group A: 4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM.

Group III: Placebo onlyActive Control1 Intervention

Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM

0 / 10Eligibility criteria met