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

Primary Purpose

Lung Diseases, Lung Cancer, Protection Against

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Curcumin C3 complex®

Lovaza®

Placebo

About this trial

This is an interventional prevention trial for Lung Diseases focused on measuring Lung RADS 3, Lung nodule, Lung cancer risk, Chemoprevention

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

H. Lee Moffitt Cancer Center and Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Curcumin C3 complex® +Lovaza®

Curcumin C3 complex® +Lovaza® +Placebo

Placebo only

Arm 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.

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.

Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM

Outcomes

Primary Outcome Measures

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.

Rate of Nodules ≥4 mm

Number of nodules ≥4 mm per study arm, post treatment.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03598309

First Posted

July 13, 2018

Last Updated

September 21, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

James and Esther King Biomedical Research Program

1. Study Identification

Unique Protocol Identification Number

NCT03598309

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 5, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

James and Esther King Biomedical Research Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Lung Cancer, Protection Against

Keywords

Lung RADS 3, Lung nodule, Lung cancer risk, Chemoprevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Curcumin C3 complex® +Lovaza®

Arm Type

Active Comparator

Arm 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.

Arm Title

Curcumin C3 complex® +Lovaza® +Placebo

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo only

Arm Type

Active Comparator

Arm Description

Placebo: Two matching placebo capsules twice a day (BID), taken by mouth, AM and PM

Intervention Type

Drug

Intervention Name(s)

Curcumin C3 complex®

Other Intervention Name(s)

Curcuminoid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lovaza®

Other Intervention Name(s)

Omega-3-Acid Ethyl Esters

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Pill with no drug or other active ingredients in it.

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change in Bronchial Nodule Size

Description

Time Frame

6 months post treatment

Title

Rate of Nodules ≥4 mm

Description

Number of nodules ≥4 mm per study arm, post treatment.

Time Frame

6 months post treatment

Secondary Outcome Measure Information:

Title

Rate of Adherence

Description

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.

Time Frame

6 months post treatment

Title

Rate of Treatment Related Adverse Events (AEs)

Description

Time Frame

Up to 30 days post treatment, approximately 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nagi Kumar, Ph.D

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnay Marshall

Phone

813-745-4673

Arnay.Marshall@moffitt.org

First Name & Middle Initial & Last Name & Degree

Nagi Kumar, Ph.D.

Phone

813-745-6885

nagi.kumar@moffitt.org

First Name & Middle Initial & Last Name & Degree

Nagi Kumar, PhD

First Name & Middle Initial & Last Name & Degree

Mark Alexandrow, PhD

First Name & Middle Initial & Last Name & Degree

Jhanelle Gray, MD

First Name & Middle Initial & Last Name & Degree

Tawee Tanventyanon, MD

First Name & Middle Initial & Last Name & Degree

Michael Alberts, MD

First Name & Middle Initial & Last Name & Degree

Lary Robinson, MD

First Name & Middle Initial & Last Name & Degree

Farah Khalil, MD

First Name & Middle Initial & Last Name & Degree

Donald Klippenstein, MD

First Name & Middle Initial & Last Name & Degree

Matthew Schabath, PhD

First Name & Middle Initial & Last Name & Degree

Michael Schell, PhD

12. IPD Sharing Statement

Links:

URL

https://www.moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE

Description

Moffitt Cancer Center Clinical Trials website

Learn more about this trial

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

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