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

Phase 2

Recruiting

• Conditions: Lung Diseases; Lung Cancer, Protection Against
• Interventions: Drug: Curcumin C3 complex®; Drug: Lovaza®; Other: Placebo

• Registration Number: NCT03598309
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-26
• Study Start: 2019-06-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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
• Able to understand and willing to sign a written informed consent document
• Participants must have normal organ and marrow function
• Willing to use contraception during the intervention period of 6 months (males and females)
• Not pregnant or lactating nor planning to become pregnant or lactate during the 6 month study intervention period..

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin C3 complex® +Lovaza® +Placebo	Lovaza®	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.
Curcumin C3 complex® +Lovaza® +Placebo	Placebo	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.
Placebo only	Placebo	Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Curcumin C3 complex® +Lovaza®	Lovaza®	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.
Curcumin C3 complex® +Lovaza®	Curcumin C3 complex®	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.
Curcumin C3 complex® +Lovaza® +Placebo	Curcumin C3 complex®	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Bronchial Nodule Size	6 months post treatment	Difference in the average change in bronchial nodule size from baseline to end of therapy at 6 months for each study arm. A lower size is taken to be the desired value for participants receiving study drug, assuming an increase in size for the placebo arm.
Rate of Nodules ≥4 mm	6 months post treatment	Number of nodules ≥4 mm per study arm, post treatment.

Secondary Outcome Measures

Name	Time	Method
Rate of Adherence	6 months post treatment	Rate of participant adherence per study arm. Proof of adherence based on study team pill counts, participant diet logs and pill logs at end of study, vs. data collected at midpoint.
Rate of Treatment Related Adverse Events (AEs)	Up to 30 days post treatment, approximately 7 months	Safety of the combined agents (Curcumin C3 complex® + Lovaza®) at 2 dose arms vs. placebo as indicated by incidence of related adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States