NCT03598309Active, not recruitingPhase 2
Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 13 Jul 2018
- Start date
- 5 Jun 2019
- Primary completion date
- 29 May 2025
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Lung cancer
- NCT number
- NCT03598309
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 19
- From 5 Jun 2019 to the primary completion date, 29 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Invasive cancer diagnosis (excluding basal cell carcinoma or skin squamous cell carcinoma) diagnosed within the last 2 years
Other
- 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).
Who the study is looking for
- 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..
Age in the registry: 55 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| H Lee Moffitt Cancer Center and Research Institute Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.