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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
19
Groups A and B 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.
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
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.
Time frame: 6 months post treatment
Rate of Nodules ≥4 mm
Number of nodules ≥4 mm per study arm, post treatment.
Time frame: 6 months post treatment
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.
Time frame: 6 months post treatment
Rate of Treatment Related Adverse Events (AEs)
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.
Time frame: Up to 30 days post treatment, approximately 7 months
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