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| ID | Type | Description | Link |
|---|---|---|---|
| 8JK03 | Other Identifier | James & Esther King Biomedical Research Group |
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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin C3 complex® +Lovaza® | Active Comparator | 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. |
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| Curcumin C3 complex® +Lovaza® +Placebo | Active Comparator | 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. |
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| Placebo only | Active Comparator | Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin C3 complex® | Drug | Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adherence | Rate of participant adherence per study arm. Proof of adherence based on study team pill counts, participant diet logs and pill logs at end of study, vs. data collected at midpoint. | 6 months post treatment |
| Rate of Treatment Related Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagi Kumar, Ph.D | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 29, 2026 | 34 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Lovaza® | Drug | Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. |
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| Placebo | Other | Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants. |
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Safety of the combined agents (Curcumin C3 complex® + Lovaza®) at 2 dose arms vs. placebo as indicated by incidence of related adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0. |
| Up to 30 days post treatment, approximately 7 months |
| D009369 | Neoplasms |
| D009930 |
| Organic Chemicals |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |