Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
2 other identifiers
interventional
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
6 years
July 13, 2018
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Change in Bronchial Nodule Size
Difference in the average change in bronchial nodule size from baseline to end of therapy at 6 months for each study arm. A lower size is taken to be the desired value for participants receiving study drug, assuming an increase in size for the placebo arm.
6 months post treatment
Rate of Nodules ≥4 mm
Number of nodules ≥4 mm per study arm, post treatment.
6 months post treatment
Secondary Outcomes (2)
Rate of Adherence
6 months post treatment
Rate of Treatment Related Adverse Events (AEs)
Up to 30 days post treatment, approximately 7 months
Study Arms (3)
Curcumin C3 complex® +Lovaza®
ACTIVE COMPARATORGroup 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® +Lovaza® +Placebo
ACTIVE COMPARATORGroup 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.
Placebo only
ACTIVE COMPARATORPlacebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Interventions
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Eligibility Criteria
You may qualify if:
- 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..
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nagi Kumar, Ph.D
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
July 26, 2018
Study Start
June 5, 2019
Primary Completion
May 29, 2025
Study Completion
May 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02