Clinical trial · Interventional
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
NCT03598309CI-TRIAL-00104155active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Protection Against | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin C3 complex® | Drug | — | UNRESOLVED |
| Lovaza® | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Curcumin C3 complex® +Lovaza®
- description
- 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.
- interventionNames
- Drug: Curcumin C3 complex®
- Drug: Lovaza®
- type
- ACTIVE_COMPARATOR
- label
- Curcumin C3 complex® +Lovaza® +Placebo
- description
- 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.
- interventionNames
- Drug: Curcumin C3 complex®
- Drug: Lovaza®
- Other: Placebo
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.