A Phase 2 interventional study of Curcumin and Laboratory Biomarker Analysis in Chronic Atrophic Gastritis and Gastric Carcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 2 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention
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.
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.
75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.
This study's enrollment of 50 is below the median of 91 across 21 interventional studies indexed under Gastritis, Atrophic.
Browse Gastritis, Atrophic studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Given PO
Also known as: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow
Correlative studies
Given PO
Ancillary studies
Also known as: Quality of Life Assessment
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.
Time frame: Baseline up to 6 months
Change in Histology Gastric Score
Will compare changes in histology gastric score for curcumin versus placebo. Correa Histopathology Scoring System values according to the histological diagnosis categories Histological diagnosis Correa Histopathology Scores (range) 1. Normal 1 2. non-atrophic gastritis(NAG) 2 3. multifocal atrophic gastritis without intestinal metaplasia (MAG) 3.25-4.00\* 4. IM (intestinal metaplasia) 4.30-5.00\* 5. Dysplasia 5.25-5.75\* 6. Gastric Cancer 6
Time frame: Baseline up to 6 months
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Will be quantified with Luminex assay. Changes in the concentrations (or categories) will be explored within and between the intervention arms. Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups. McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm. Graphical methods (i.e. boxplots, scatter plots, etc.) will also be used to describe the data.
Time frame: Baseline up to 6 months
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
Will be assessed by immunohistochemistry. Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups. McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm. Graphical methods (i.e. boxplots, scatter plots, etc.) will also be used to describe the data.
Time frame: Baseline up to 6 months
Proinflammatory Cytokine Genotype Status (IL-1beta, IL-8, and TNFalpha Single Nucleotide Polymorphisms)
Will be examined in relation to the outcomes above to further characterize the at-risk population and generate hypotheses for future studies.
Time frame: At baseline
| Milestone | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
| Started | 24 | 26 |
| Completed | 23 | 25 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| pg/mL | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
| Antrum: IL-1beta Difference | 0.0 (-4.2 to 10.9) | -0.1 (-5.5 to 4.1) |
| Body: IL-1beta Difference | 0.0 (-5.2 to 4.2) | 0.1 (-0.8 to 8.6) |
Will compare changes in histology gastric score for curcumin versus placebo. Correa Histopathology Scoring System values according to the histological diagnosis categories Histological diagnosis Correa Histopathology Scores (range) 1. Normal 1 2. non-atrophic gastritis(NAG) 2 3. multifocal atrophic gastritis without intestinal metaplasia (MAG) 3.25-4.00\* 4. IM (intestinal metaplasia) 4.30-5.00\* 5. Dysplasia 5.25-5.75\* 6. Gastric Cancer 6
| scores on a scale | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
| Correa Score Difference (Puerto Rico data) central review | 0.0 (-2.8 to 3.6) | 0.0 (-3.6 to 2.6) |
| Correa Score Difference (UAB data) | 0.0 (-3.6 to 3.6) | 0.0 (-3.9 to 3.5) |
Will be quantified with Luminex assay. Changes in the concentrations (or categories) will be explored within and between the intervention arms. Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups. McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm. Graphical methods (i.e. boxplots, scatter plots, etc.) will also be used to describe the data.
| pg/mL | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
| Antrum: TNF-alpha Difference | -0.1 (-3.8 to 5.7) | 0.0 (-1.8 to 8.7) |
| Antrum: IP-10 Difference | 8.0 (-135.7 to 285.9) | 14.3 (-218.3 to 179.2) |
| Body: IP-10 Difference | 1.2 (-356.5 to 217.0) | 5.2 (-132.3 to 157.9) |
| Body: TNF-alpha Difference | 0.0 (-1.8 to 4.6) | 0.0 (-8.0 to 12.0) |
| Antrum: IL-8 Difference | -0.3 (-30.7 to 12.4) | -0.2 (-55.4 to 385.2) |
| Body: IL-8 Difference | 0.0 (-1.8 to 4.6) | 0.0 (-8.0 to 12.0) |
Will be assessed by immunohistochemistry. Fisher's exact tests, Wilcoxon rank sum tests, and two-sample t-tests will be used to assess differences between groups. McNemar's tests, Wilcoxon signed rank tests, and paired sample t-tests will be used to assess differences within each arm. Graphical methods (i.e. boxplots, scatter plots, etc.) will also be used to describe the data.
| Participants | Arm I (Curcumin) | Arm II (Placebo) |
|---|---|---|
| DNA Damage: Baseline — < 1% | 18 | 19 |
| DNA Damage: Baseline — 1-5% | 2 | 4 |
| DNA Damage: Baseline — >5% | 2 | 1 |
| DNA Damage: Baseline — Missing | 0 | 1 |
| DNA Damage: Month 6 — < 1% | 19 | 13 |
| DNA Damage: Month 6 — 1-5% | 2 | 10 |
| DNA Damage: Month 6 — >5% | 1 | 1 |
| DNA Damage: Month 6 — Missing | 0 | 1 |
Will be examined in relation to the outcomes above to further characterize the at-risk population and generate hypotheses for future studies.
Results for this outcome have not been posted.
Collected over Up to 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm II (Placebo) | 0/26 (0%) | 0/26 (0%) | 14/26 (53.8%) |
| Arm I (Curcumin) | 0/24 (0%) | 0/24 (0%) | 12/24 (50%) |
| Event | Arm II (Placebo) | Arm I (Curcumin) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 3/26 | 3/24 |
| Flu like symptomsGeneral disorders | 0/26 | 3/24 |
| Back painMusculoskeletal and connective tissue disorders | 2/26 | 3/24 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 3/26 | 2/24 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/26 | 1/24 |
| Upper respiratory infectionInfections and infestations | 1/26 | 2/24 |
| Abdominal painGastrointestinal disorders | 2/26 | 1/24 |
| NauseaGastrointestinal disorders | 2/26 | 0/24 |
| VomitingGastrointestinal disorders | 2/26 | 1/24 |
| Bronchial infectionInfections and infestations | 2/26 | 1/24 |
| Age, Continuous(years) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Mean | 62.0 ± 10.51 | 60.4 ± 10.77 | 61.2 ± 10.57 |
| Sex: Female, Male(Participants) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Female | 14 | 17 | 31 |
| Male | 10 | 9 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 24 | 48 |
| Not Hispanic or Latino | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 11 | 13 | 24 |
| More than one race | 10 | 12 | 22 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| Honduras | 10 | 12 | 22 |
| Puerto Rico | 14 | 14 | 28 |
| Gastric mucosal histologic diagnosis(Participants) | Arm I (Curcumin) | Arm II (Placebo) | Total |
|---|---|---|---|
| MAG (multifocal atrophic gastritis) | 5 | 6 | 11 |
| GIM (gastric intestinal metaplasia) | 16 | 17 | 33 |
| Both (from screening endoscopic gastroduodenoscopy or EGD) | 3 | 3 | 6 |
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