- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782949
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Randomized, Double-Blind, Placebo-Controlled Trial of Meriva® (Curcuminoids) as a Candidate Chemoprevention Agent for Gastric Carcinogenesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the change in gastric mucosal interleukin 1beta (IL-1beta) cytokine level, quantified by Luminex assay technology, after a 6-month intervention in participants randomly assigned to the curcumin (Meriva [curcuminoids]) versus placebo arms.
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of Meriva versus placebo. II. To compare changes in Histology Gastric Score (HGS) from baseline to 6 months for Meriva versus placebo.
III. To compare changes in additional gastric mucosal cytokine/chemokine levels (interleukin 8 [IL-8], tumor necrosis factor-alpha [TNFalpha], and inducible protein 10 [IP-10]; quantified by Luminex assay).
IV. To compare changes in gastric mucosal deoxyribonucleic acid (DNA) damage as assessed by immunohistochemistry (IHC), of the biomarkers 8-hydroxy-2'-deoxyguanosine (8-OHdG) and phosphorylated subtype of histone H2A (H2AX).
V. To explore associations between proinflammatory cytokine genotype status (IL-1beta, IL-8, and TNFalpha single nucleotide polymorphisms [SNPs]; characterized at baseline) and the above outcomes.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM 1: Patients receive curcumin orally (PO) twice daily (BID) for 180 days in the absence of unacceptable toxicity.
ARM 2: Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and 7 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Santa Rosa De Copan, Honduras, 41101
- Hospital Regional de Occidente
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San Juan, Puerto Rico, 00936
- University of Puerto Rico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PRE-REGISTRATION INCLUSION CRITERIA
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to undergo screening tests and procedures
- Willingness to provide blood and tissue samples for safety/toxicity monitoring and biomarker analyses
- Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids
- REGISTRATION/RANDOMIZATION INCLUSION CRITERIA
- Histologically-confirmed chronic multifocal atrophic gastritis (MAG) and/or gastric intestinal metaplasia (GIM)
- Helicobacter pylori negative, defined as negative stool antigen testing and negative histological examination
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- Aspartate transaminase (AST), alanine transferase (ALT) within institutional limits of normal or judged to be not clinically significant by the investigator
- Alkaline phosphatase within institutional limits of normal or judged to be not clinically significant by the investigator
- Platelets within institutional limits of normal or judged to be not clinically significant by the investigator
- Hemoglobin within institutional limits of normal or judged to be not clinically significant by the investigator
- White blood cells (WBC) within institutional limits of normal or judged to be not clinically significant by the investigator
- Blood urea nitrogen (BUN) within institutional limits of normal or judged to be not clinically significant by the investigator
- Total bilirubin within institutional limits of normal or judged to be not clinically significant by the investigator
- Creatinine within institutional limits of normal or judged to be not clinically significant by the investigator
- Not pregnant or breast feeding; Note: The effects of Meriva on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, individuals of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
Exclusion Criteria:
- PRE-REGISTRATION EXCLUSION CRITERIA
- History of other malignancy =< 2 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer
- History of colorectal cancer; exception: individuals with stage I or II colorectal cancer who have not received any chemotherapy
- Known diagnosis of human immunodeficiency virus (HIV); Note: An HIV screening test does not have to be performed to evaluate this criterion
- History of gastric surgery
- Receiving any other investigational agents
- Use of any anticoagulation medications, such as warfarin or Coumadin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding; Note: Pregnant women are excluded from this study; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Meriva, breastfeeding should be discontinued if the mother is treated with Meriva
- REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA
- Receiving any other investigational, anticoagulation, and/or chemotherapy agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Meriva
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm I (curcumin)
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
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Correlative studies
Ancillary studies
Other Names:
Given PO
Other Names:
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Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
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Correlative studies
Ancillary studies
Other Names:
Given PO
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa
Time Frame: Baseline up to 6 months
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Will be measured by Luminex assay.
If the data are not normally distributed, the Wilcoxon Rank-Sum test will be used.
The 95% confidence intervals will also be provided.
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Baseline up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Histology Gastric Score
Time Frame: Baseline up to 6 months
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Will compare changes in histology gastric score for curcumin versus placebo. Correa Histopathology Scoring System values according to the histological diagnosis categories Histological diagnosis Correa Histopathology Scores (range)
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Baseline up to 6 months
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Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Time Frame: Baseline up to 6 months
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Will be quantified with Luminex assay.
Changes in the concentrations (or categories) will be explored within and between the intervention arms.
Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups.
McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm.
Graphical methods (i.e.
boxplots, scatter plots, etc.) will also be used to describe the data.
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Baseline up to 6 months
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Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
Time Frame: Baseline up to 6 months
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Will be assessed by immunohistochemistry. Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups.
McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm.
Graphical methods (i.e.
boxplots, scatter plots, etc.) will also be used to describe the data.
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Baseline up to 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proinflammatory Cytokine Genotype Status (IL-1beta, IL-8, and TNFalpha Single Nucleotide Polymorphisms)
Time Frame: At baseline
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Will be examined in relation to the outcomes above to further characterize the at-risk population and generate hypotheses for future studies.
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At baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcia R Cruz-Correa, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Pathological Conditions, Anatomical
- Gastritis
- Atrophy
- Gastritis, Atrophic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- NCI-2016-00713 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (U.S. NIH Grant/Contract)
- N01-CN-2012-00042
- N01CN00042 (U.S. NIH Grant/Contract)
- MAY2015-05-01 (Other Identifier: DCP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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