Clinical trial NCT03598309: Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers
Official title: Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lung Diseases
Lung Cancer, Protection Against
Keywords: Lung RADS 3
Lung nodule
Lung cancer risk
Chemoprevention
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2018-07-26
Enrollment: 19
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Mean Change in Bronchial Nodule Size
timeFrame: 6 months post treatment
measure: Rate of Nodules ≥4 mm
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Rate of Adherence
timeFrame: 6 months post treatment
measure: Rate of Treatment Related Adverse Events (AEs)
timeFrame: Up to 30 days post treatment, approximately 7 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Nagi Kumar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: