Tampa, Florida 33612

  • Lung Cancer, Protection Against

Purpose:

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.


Criteria:

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 persistent or slowly increasing part-solid or non-solid lung nodule >4mm mean diameter detected by two serial yearly screening low dose CT 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).


NCT ID:

NCT03598309


Primary Contact:

Principal Investigator
Nagi Kumar, Ph.D
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States

Kayoko Kennedy
Phone: 813-745-1947
Email: kayoko.kennedy@moffitt.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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