Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
NCT ID: NCT03598309
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
19 participants
INTERVENTIONAL
2019-06-05
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Curcumin C3 complex® +Lovaza®
Group A:
4 grams Lovaza®, 2 grams twice a day (BID). 2 grams by mouth daily, AM and PM 8,000 mgs CUR Curcumin C3 complex® tablets, divided into 2 doses. 4 grams by mouth, twice a day, AM and PM.
Curcumin C3 complex®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Curcumin C3 complex® +Lovaza® +Placebo
Group B:
2 grams Lovaza®, 1 gram twice a day, AM and PM. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs twice a day, AM and PM.
1 placebo capsule twice a day, AM and PM.
Curcumin C3 complex®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Placebo only
Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Interventions
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Curcumin C3 complex®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
55 Years
ALL
Yes
Sponsors
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James and Esther King Biomedical Research Program
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Nagi Kumar, Ph.D
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trials website
Other Identifiers
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8JK03
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-19622
Identifier Type: -
Identifier Source: org_study_id
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