Chronic Atrophic GastritisPhase 2NCT02782949
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
A Phase 2 study testing Curcumin, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Chronic Atrophic Gastritis and Gastric Carcinoma, run by National Cancer Institute (NCI) at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Atrophic Gastritis, Gastric Carcinoma
- What is being tested?
- Curcumin, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Apr 2017to 1 Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Meriva® (Curcuminoids) as a Candidate Chemoprevention Agent for Gastric Carcinogenesis
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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).
- 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.
- Conditions
- Chronic Atrophic Gastritis, Gastric Carcinoma
- Being tested
- Curcumin, Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment
- Medical subject headings
- Gastritis, Atrophic, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Placebo AdministrationOther
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (curcumin) | Experimental | Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity. Receives: Drug: Curcumin; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa
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.
Measured: Baseline up to 6 months
Secondary outcomes (3)
Change in Histology Gastric Score
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)
- Normal 1
- non-atrophic gastritis(NAG) 2
- multifocal atrophic gastritis without intestinal metaplasia (MAG) 3.25-4.00*
- IM (intestinal metaplasia) 4.30-5.00*
- Dysplasia 5.25-5.75*
- Gastric Cancer 6
Measured: Baseline up to 6 months
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
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.
Measured: Baseline up to 6 months
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
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.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start4 Apr 2017
- Primary completion6 Oct 2022
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Atrophic GastritisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcia R Cruz-Correa, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782949
- Sponsor's protocol ID
- NCI-2016-00713
- Other IDs
- NCI-2016-00713, N01-CN-2012-00042, MAY2015-05-01, MAY2015-05-01, N01CN00042, P30CA015083
- Status last verified
- Sep 2026
- First submitted
- 25 May 2016
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gonzalez-Pons M, Dominguez RL, Montalvan-Sanchez EE, Foster NR, Strand CA, Hernandez-Marrero J, Norwood DA, McMurray RP, Rivera Roman KL, Centeno-Girona H, Rodriguez-Murillo A, Ghandour F, Al Diffalha S, Samadder NJ, Umar A, Richmond E, Rodriguez LM, Limburg PJ, Morgan DR, Cruz-Correa M. Randomized, Double-Blind, Placebo-Controlled Trial of Meriva (Curcuminoids) as a Candidate Chemoprevention Agent for Gastric Carcinogenesis. Cancer Prev Res (Phila). 2026 Jul 1;19(7):403-413. doi: 10.1158/1940-6207.CAPR-25-0363.
PubMed 42077070Montalvan-Sanchez EE, Hernandez-Marrero J, Norwood DA, Gonzalez-Pons M, Dominguez RL, Rodriguez LM, Richmond E, Limburg PJ, Cruz-Correa M, Morgan DR. Establishment of a Mesoamerican-Caribbean South-South Research Platform: Challenges in the Meriva (Curcuminoids) Gastric Cancer Chemoprevention Trial. Cancer Prev Res (Phila). 2024 Dec 3;17(12):549-555. doi: 10.1158/1940-6207.CAPR-23-0345.
PubMed 39148307