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OpenTrials
Active, Not Recruiting

NCT Number: NCT03598309

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Diseases Lung Cancer, Protection Against Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Curcumin C3 complex®

Drug

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

Other names: Curcuminoid

Lovaza®

Drug

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

Other names: Omega-3-Acid Ethyl Esters

Placebo

Other

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

Other names: Pill with no drug or other active ingredients in it.

Primary outcomes

  1. Mean Change in Bronchial Nodule Size

    Time frame: 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.

  2. Rate of Nodules ≥4 mm

    Time frame: 6 months post treatment

    Number of nodules ≥4 mm per study arm, post treatment.

Secondary outcomes

  1. Rate of Adherence

    Time frame: 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.

  2. Rate of Treatment Related Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • James and Esther King Biomedical Research Program

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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