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

NCT03598309 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-02-27

No results posted yet for this study

Summary

The purpose of this study is to find out if an investigational combination drug called Lovaza (made with fish oils)+Curcumin C3 Complex (made from a root called curcumin) can help reduce the size of lung nodules. Researchers also want to find out if the combination of Lovaza+Curcumin C3 Complex is safe and tolerable.

Conditions

  • Lung Diseases
  • Lung Cancer, Protection Against

Interventions

DRUG

Curcumin C3 complex®

Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.

DRUG

Lovaza®

Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.

OTHER

Placebo

Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.

Sponsors & Collaborators

  • James and Esther King Biomedical Research Program

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Nagi Kumar, Ph.D · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2025-05-29
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598309 on ClinicalTrials.gov