Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers (NCT03598309) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
United States19 participantsStarted 2019-06-05
Plain-language 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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Bronchial Nodule Size
Timeframe: 6 months post treatment
2
Rate of Nodules ≥4 mm
Timeframe: 6 months post treatment
Trial details
NCT IDNCT03598309
SponsorH. Lee Moffitt Cancer Center and Research Institute