Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers

STATUS

Recruiting
End date

Dec 22, 2023
participants needed

75
sponsor

H. Lee Moffitt Cancer Center and Research Institute

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Updated on 22 October 2022

See if I qualify

cancer

lung cancer

cigarette smoke

lung cancer screening

Accepts healthy volunteers

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.

Details

Condition	Lung Diseases, Lung Cancer, Protection Against
Treatment	Placebo, Curcumin C3 complex®, Lovaza®
Clinical Study Identifier	NCT03598309
Sponsor	H. Lee Moffitt Cancer Center and Research Institute
Last Modified on	22 October 2022

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Eligibility		Yes	No	Not Sure
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 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)

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Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers