Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former and Current Smokers

Lung Diseases Clinical Trial

Official title:

Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former and Current Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598309
• Other study ID #: MCC-19622
• Secondary ID: 8JK03
• Status: Recruiting
• Phase: Phase 2
• Start date: June 5, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer, Protection Against
• Lung Diseases

Intervention

Drug:
• Curcumin C3 complex®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
• Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.

Other:
• Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	James and Esther King Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of Nodules =4 mm	Number of nodules =4 mm per study arm, post treatment.	6 months post treatment
Secondary	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
Secondary	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.	Up to 30 days post treatment, approximately 7 months

External Links

•   Moffitt Cancer Center Clinical Trials website