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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Atrophic Gastritis
• Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Curcumin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-04-04
• Primary completion: 2022-10-06
• Completion: 2026-04-01
• First posted: 2016-05-26
• Last updated: 2026-04-02
• Results posted: 2024-03-05

Locations

2 sites across 2 countries: Honduras, Puerto Rico

Regulatory

• FDA-regulated drug study