Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Mean Change in Bronchial Nodule Size
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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..
排除标准
- •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).
研究组 & 干预措施
Curcumin C3 complex® +Lovaza®
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.
干预措施: Curcumin C3 complex® (Drug)
Curcumin C3 complex® +Lovaza®
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.
干预措施: Lovaza® (Drug)
Curcumin C3 complex® +Lovaza® +Placebo
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.
干预措施: Curcumin C3 complex® (Drug)
Curcumin C3 complex® +Lovaza® +Placebo
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.
干预措施: Lovaza® (Drug)
Curcumin C3 complex® +Lovaza® +Placebo
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.
干预措施: Placebo (Other)
Placebo only
Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
干预措施: Placebo (Other)
结局指标
主要结局
Mean Change in Bronchial Nodule Size
时间窗: 6 months post treatment
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.
Rate of Nodules ≥4 mm
时间窗: 6 months post treatment
Number of nodules ≥4 mm per study arm, post treatment.
次要结局
- Rate of Adherence(6 months post treatment)
- Rate of Treatment Related Adverse Events (AEs)(Up to 30 days post treatment, approximately 7 months)