Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia

NCT02782949 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 5 other identifiers: NCI-2016-00713N01-CN-2012-00042MAY2015-05-01N01CN00042P30CA015083
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Atrophic Gastritis; Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to 6 months

Secondary Outcomes (3)

• Change in Histology Gastric Score

  Baseline up to 6 months

• Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)

  Baseline up to 6 months

• Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage

  Baseline up to 6 months

Other Outcomes (1)

• Proinflammatory Cytokine Genotype Status (IL-1beta, IL-8, and TNFalpha Single Nucleotide Polymorphisms)

  At baseline

Study Arms (2)

Arm I (curcumin)

EXPERIMENTAL

Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.

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.

Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Other: Quality-of-Life Assessment

Interventions

Curcumin DRUG

Given PO

Also known as: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow

Arm I (curcumin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (curcumin); Arm II (placebo)

Placebo Administration OTHER

Given PO

Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (curcumin); Arm II (placebo)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Receiving any other investigational, anticoagulation, and/or chemotherapy agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Meriva

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Hospital Regional de Occidente

Santa Rosa de Copán, 41101, Honduras

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Dr Paul J. Limburg
• Organization: Mayo Clinic

limburg.paul@mayo.edu

507-284-2511

Study Officials

• Marcia R Cruz-Correa

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 26, 2016
• Study Start: April 4, 2017
• Primary Completion: October 6, 2022
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 21, 2026
• Results First Posted: March 5, 2024

Record last verified: 2026-03

Locations

PR (1); HO (1)