Clinical trial · Interventional
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
NCT02782949CI-TRIAL-00108969active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Atrophic Gastritis | — | UNRESOLVED | — |
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (curcumin)
- description
- Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
- interventionNames
- Drug: Curcumin
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDGonzalez-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. PMID 42077070
- DERIVEDMontalvan-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. PMID 39148307