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Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic

Gastritis or Gastric Intestinal Metaplasia

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ClinicalTrials.gov Identifier: NCT02782949

Recruitment Status  : Recruiting

First Posted  : May 26, 2016
Last Update Posted  : December 17, 2019

See Contacts and Locations

Sponsor:
National Cancer Institute (NCI)

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record

Study Description Go to

Brief Summary:
This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer in patients with
chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin is an antioxidant compound found in plants
that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease  Intervention/treatment  Phase 

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Chronic Atrophic Gastritis Drug: Curcumin Phase 2

Other: Laboratory Biomarker Analysis

Other: Placebo Administration

Other: Quality-of-Life Assessment

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 Design Go to

Study Type  :
Interventional (Clinical Trial)

Estimated Enrollment  :
100 participants

Allocation:
Randomized

Intervention Model:
Parallel Assignment

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Masking:
Double (Participant, Investigator)

Primary Purpose:
Prevention

Official Title:
Randomized, Double-Blind, Placebo-Controlled Trial of Meriva® (Curcuminoids) as a Candidate
Chemoprevention Agent for Gastric Carcinogenesis

Actual Study Start Date  :

April 4, 2017

Estimated Primary Completion Date  :

December 1, 2020

Estimated Study Completion Date  :

December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions Go to

Arm  Intervention/treatment 

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Arm  Intervention/treatment 

Experimental: Arm I (curcumin) Drug: Curcumin

Patients receive curcumin PO BID for 180 days Given PO
in the absence of unacceptable toxicity. Other Names:
C.I. 75300
C.I. Natural Yellow 3
Diferuloylmethane
Turmeric Yellow

Other: Laboratory Biomarker Analysis

Correlative studies

Other: Quality-of-Life Assessment

Ancillary studies
Other Name: Quality of Life Assessment

Placebo Comparator: Arm II (placebo) Other: Laboratory Biomarker Analysis

Patients receive placebo PO BID for 180 days in Correlative studies
the absence of unacceptable toxicity.
Other: Placebo Administration
Given PO

Other: Quality-of-Life Assessment

Ancillary studies
Other Name: Quality of Life Assessment

Outcome Measures Go to

Primary Outcome Measures  :

1. Absolute change in IL-1beta cytokine levels in the gastric mucosa [ Time Frame: Baseline up to 6
months ]

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.

Secondary Outcome Measures  :

1. Incidence of adverse events [ Time Frame: From time of first dose of curcumin up to 7 months ]
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Will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events
version 4. The maximum grade for each type of adverse event will be recorded for each
participant and frequency tables will be reviewed to determine the overall patterns. The number
and severity of adverse events (overall and by intervention group) will be tabulated and
summarized.

2. Change in histology gastric score [ Time Frame: Baseline up to 6 months ]

Will compare changes in histology gastric score for curcumin versus placebo.

3. Additional gastric mucosal cytokine/chemokine levels (IL-8, TNFalpha, and IP-10)

[ Time Frame: Baseline up to 6 months ]

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.

4. Gastric mucosal deoxyribonucleic acid (DNA) damage [ Time Frame: Baseline up to 6 months ]

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.

Other Outcome Measures:

1. Proinflammatory cytokine genotype status (IL-1beta, IL-8, and TNFalpha single nucleotide
polymorphisms) [ Time Frame: At baseline ]

Will be examined in relation to the outcomes above to further characterize the at-risk population
and generate hypotheses for future studies.

Eligibility Criteria Go to

Information from the National Library of Medicine

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Choosing to participate in a study is an important personal decision. Talk with your doctor and family
members or friends about deciding to join a study. To learn more about this study, you or your doctor
may contact the study research staff using the contacts provided below. For general information,
Learn About Clinical Studies.

Ages Eligible for Study:

21 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

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

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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

Contacts and Locations Go to

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.

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782949

Locations

Honduras

Hospital Regional de Occidente Not yet recruiting

Santa Rosa De Copan, Honduras, 41101

Contact: Ricardo L. Dominguez 504-2-26620107 ricardoleoneldominguez@yahoo.com
Principal Investigator: Ricardo L. Dominguez

Puerto Rico

University of Puerto Rico Recruiting

San Juan, Puerto Rico, 00936

Contact: Marcia R. Cruz-Correa 787-772-8300 marcia.cruz1@upr.edu
Principal Investigator: Marcia R. Cruz-Correa

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Marcia R Cruz-Correa Mayo Clinic

More Information Go to

Responsible Party:
National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:
NCT02782949 History of Changes

Other Study ID Numbers:

NCI-2016-00713
NCI-2016-00713 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01-CN-2012-00042
MAY2015-05-01 ( Other Identifier: Mayo Clinic )
MAY2015-05-01 ( Other Identifier: DCP )
N01CN00042 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )

First Posted:
May 26, 2016 Key Record Dates

Last Update Posted:

December 17, 2019

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Last Verified:
December 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

No

Additional relevant MeSH terms:

Curcumin
Gastritis
Gastritis, Atrophic
Atrophy
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach 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

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