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Trial record 12 of 80 for:    "curcumin" and "cancer"

Phase II Trial to Modulate Intermediate Endpoint Biomarkers in Former Smokers

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ClinicalTrials.gov Identifier: NCT03598309
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Lung Diseases Lung Cancer, Protection Against Drug: Curcumin C3 complex® Drug: Lovaza® Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase II Trial of Investigational Agents to Modulate Intermediate Endpoint Biomarkers, Including Pulmonary Nodules, in Former Smokers
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Curcumin C3 complex® +Lovaza®

Group A:

4 grams Lovaza®, 2 grams twice a day (BID). 8,000 mgs CUR Curcumin C3 complex® tablets, 4,000 mgs BID.

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 Name: 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 Name: Omega-3-Acid Ethyl Esters

Active Comparator: Curcumin C3 complex® +Lovaza® +Placebo

Group B:

2 grams Lovaza®, 1 gram BID. 4,000 mgs CUR Curcumin C3 complex® tablets, 2,000 mgs BID.

1 placebo capsule BID.

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 Name: 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 Name: 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 Name: Pill with no drug or other active ingredients in it.

Active Comparator: Placebo only
Placebo: Two matching placebo capsules twice a day (BID).
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 Name: Pill with no drug or other active ingredients in it.




Primary Outcome Measures :
  1. 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.

  2. Rate of Nodules ≥4 mm [ Time Frame: 6 months post treatment ]
    Number of nodules ≥4 mm per study arm, post treatment.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 55 years of age or older
  • Group one: former smokers who have a diagnosis of a Lung RADS 3
  • Group two: former smokers with lung cancer >/= years ago, with subsolid nodule(s) that are slowly growing or stable on CT for <3 years
  • Group three: former smokers without history of lung cancer, and nodule requirements the same as group 2
  • Group four: former smokers with lung cancer >/= 2 years ago, who have one or more subsolid nodules with Computer Tomography (CT), characteristics and patient risk factors such as their lung cancer expert clinician deems that they have a follow up CT in 6 months.
  • 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 and substitute with 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598309


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Kayoko Kennedy    813-745-1947    kayoko.kennedy@moffitt.org   
Contact: Nagi Kumar, Ph.D.    813-745-6885    nagi.kumar@moffitt.org   
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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
Investigators
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Principal Investigator: Nagi Kumar, Ph.D H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03598309     History of Changes
Other Study ID Numbers: MCC-19622
8JK03 ( Other Identifier: James & Esther King Biomedical Research Group )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Lung RADS 3
Lung nodule
Lung cancer risk
Chemoprevention
Additional relevant MeSH terms:
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Curcumin
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action