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

February 20, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute
        • Contact:
        • Principal Investigator:
          • Nagi Kumar, PhD
        • Sub-Investigator:
          • Mark Alexandrow, PhD
        • Sub-Investigator:
          • Jhanelle Gray, MD
        • Sub-Investigator:
          • Tawee Tanventyanon, MD
        • Sub-Investigator:
          • Michael Alberts, MD
        • Sub-Investigator:
          • Lary Robinson, MD
        • Sub-Investigator:
          • Farah Khalil, MD
        • Sub-Investigator:
          • Donald Klippenstein, MD
        • Sub-Investigator:
          • Matthew Schabath, PhD
        • Sub-Investigator:
          • Michael Schell, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • Curcuminoid
Drug: Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Other Names:
  • Omega-3-Acid Ethyl Esters
Active Comparator: 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.
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.
Other Names:
  • Curcuminoid
Drug: Lovaza®
Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Other Names:
  • Omega-3-Acid Ethyl Esters
Other: Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Other Names:
  • Pill with no drug or other active ingredients in it.
Active Comparator: Placebo only
Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM
Other: Placebo
Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
Other Names:
  • Pill with no drug or other active ingredients in it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Bronchial Nodule Size
Time Frame: 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.
6 months post treatment
Rate of Nodules ≥4 mm
Time Frame: 6 months post treatment
Number of nodules ≥4 mm per study arm, post treatment.
6 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Adherence
Time Frame: 6 months post treatment
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
Rate of Treatment Related Adverse Events (AEs)
Time Frame: Up to 30 days post treatment, approximately 7 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

James and Esther King Biomedical Research Program

Investigators

  • Principal Investigator: Nagi Kumar, Ph.D, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-19622
  • 8JK03 (Other Identifier: James & Esther King Biomedical Research Group)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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