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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: James and Esther King Biomedical Research Program
• Treatments: Curcumin

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).