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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 current or former smoker with a lung scan showing a small, possibly concerning spot.

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I am willing to use birth control for 6 months during the study.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change in Bronchial Nodule Size

Rate of Nodules ≥4 mm

Secondary outcome measures

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 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,417 Total Patients Enrolled

James and Esther King Biomedical Research ProgramOTHER

13 Previous Clinical Trials

1,759 Total Patients Enrolled

Nagi Kumar, Ph.DPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

1 Previous Clinical Trials

Media Library

Curcumin C3 complex (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03598309 — Phase 2

Lung Disease Clinical Trial 2023: Curcumin C3 complex Highlights & Side Effects. Trial Name: NCT03598309 — Phase 2

Curcumin C3 complex (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598309 — Phase 2

Lung Disease Research Study Groups: Curcumin C3 complex® +Lovaza® +Placebo, Curcumin C3 complex® +Lovaza®, Placebo only

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pioneering research endeavor?

"As far back as 2005, Abbott sponsored a trial testing Curcumin C3 complex® +Lovaza®, which eventually led to the drug being approved for Phase 4. Presently, there are 22 active studies of this medication taking place in 19 cities across 8 countries."

Answered by AI

Has there been any prior research that has incorporated Curcumin C3 complex® +Lovaza®?

"At the present moment, 22 investigations into Curcumin C3 complex® +Lovaza® are in progress. 5 of these experiments have progressed to Phase 3. Moreover, 30 medical sites nationwide are looking at this intervention with many being based in Kansas City, Kansas."

Answered by AI

Has the FDA sanctioned the combination of Curcumin C3 Complex® and Lovaza®?

"Our team at Power assessed the safety of Curcumin C3 Complex® +Lovaza® to be a 2, as this trial is currently in Phase 2; indicating that there are some data points demonstrating its security yet none proving effectiveness."

Answered by AI

How many participants are enrolled in this research initiative?

"Affirmative. According to the details posted on clinicaltrials.gov, this investigation is actively seeking participants; it was initially uploaded on June 5th 2019 and recently revised on September 30th 2022. As of now, they require 75 individuals from one medical facility."

Answered by AI

Are there currently any opportunities for participants to join this experiment?

"That is accurate. As per the information on clinicaltrials.gov, this medical trial which was first posted in June 2019 is presently recruiting participants. 75 individuals are needed from a single clinic for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers

2019. "Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03598309.

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