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 range55 Years
SexALL
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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…
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