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
Sponsor: National Cancer Institute (NCI)
Listed as NCT02782949, this observational or N/A phase trial focuses on Chronic Atrophic Gastritis and Gastric Carcinoma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 44 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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...
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.
Status Flow
Change History
44 versions recorded-
Apr 21, 2026 — Present [daily]
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First recorded
Eligibility 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.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .