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

  • End date
    Dec 22, 2023
  • participants needed
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 22 October 2022
lung cancer
cigarette smoke
lung cancer screening
Accepts healthy volunteers


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.

Condition Lung Diseases, Lung Cancer, Protection Against
Treatment Placebo, Curcumin C3 complex®, Lovaza®
Clinical Study IdentifierNCT03598309
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on22 October 2022


Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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