NCT03598309

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

Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-06-05
• Primary completion: 2025-05-29
• Completion: 2026-05-01
• First posted: 2018-07-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study