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Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers | Clinical Trials | Clareo Health

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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

NCT03598309•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, 55 years of age or older
•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 part-solid or non-solid lung nodule ≥4mm mean diameter detected during screening LDCT or regular CT scans
•History of cigarette smoking with ≥ 20 pack years
•All current smokers should accept to receive smoking cessation
•Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 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
+4 more criteria

Exclusion Criteria

•Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
•Inability to undergo CT
•Newly diagnosed nodule meeting Lung-RADS 4 criteria
•Have taken doxycycline or tetracycline less than or equal to 2 weeks
•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).

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

June 5, 2019

Primary Completion Date

May 29, 2025

Completion Date

May 1, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Lung DiseasesLung Cancer, Protection Against

Interventions

Curcumin C3 complex®

DRUG

Lovaza®

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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