Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
Status and phase
Enrolling
Phase 2
Conditions
Lung Diseases
Lung Cancer, Protection Against
Treatments
Drug: Curcumin C3 complex®
Drug: Lovaza®
Other: Placebo
Details and patient eligibility
About
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.
Enrollment
75 estimated patients
Sex
All
Ages
55+ years old
Volunteers
Accepts Healthy Volunteers
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).
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
75 participants in 3 patient groups
Curcumin C3 complex® +Lovaza®
Active Comparator group
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.
Treatment:
Drug: Lovaza®
Drug: Curcumin C3 complex®
Curcumin C3 complex® +Lovaza® +Placebo
Active Comparator group
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.
Treatment:
Other: Placebo
Drug: Lovaza®
Drug: Curcumin C3 complex®
Placebo only
Active Comparator group
Description:
Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Treatment:
Other: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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