Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 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).

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT03598309

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Kayoko Kennedy
Contact
813-745-1947
[email protected]
Nagi Kumar, Ph.D.
Contact
813-745-6885
[email protected]
Nagi Kumar, PhD
Principal Investigator
Mark Alexandrow, PhD
Sub-Investigator
Jhanelle Gray, MD
Sub-Investigator
Tawee Tanventyanon, MD
Sub-Investigator
Michael Alberts, MD
Sub-Investigator
Lary Robinson, MD
Sub-Investigator
Farah Khalil, MD
Sub-Investigator
Donald Klippenstein, MD
Sub-Investigator
Matthew Schabath, PhD
Sub-Investigator
Michael Schell, PhD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT03598309

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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