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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT02782949
• Date of registration: 25/05/2016
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
• Scientific title: Randomized, Double-Blind, Placebo-Controlled Trial of Meriva® (Curcuminoids) as a Candidate Chemoprevention Agent for Gastric Carcinogenesis
• Date of first enrolment: April 4, 2017
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02782949
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Honduras, Puerto Rico

Contacts

• Name: Marcia R Cruz-Correa
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Atrophic Gastritis

Intervention(s)

Other: Placebo Administration

Other: Quality-of-Life Assessment

Drug: Curcumin

Other: Laboratory Biomarker Analysis

Primary Outcome(s)

Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa [Time Frame: Baseline up to 6 months]

Secondary Outcome(s)

Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10) [Time Frame: Baseline up to 6 months]

Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage [Time Frame: Baseline up to 6 months]

Change in Histology Gastric Score [Time Frame: Baseline up to 6 months]

Secondary ID(s)

N01CN00042

N01-CN-2012-00042

NCI-2016-00713

P30CA015083

MAY2015-05-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/03/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02782949