Trial · NCT02782949
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
NCT02782949, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-03-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia. Trials, record NCT02782949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02782949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
- NCT number
- NCT02782949
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Chronic Atrophic Gastritis, Gastric Carcinoma
- Interventions
- Curcumin, Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment
- First posted
- 2016-05-26
- Last updated
- 2026-09-14
- Results first posted
- 2024-03-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Baseline up to 6 months | 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. |
| Secondary | Change in Histology Gastric Score | Baseline up to 6 months | 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 |
| Secondary | Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10) | Baseline up to 6 months | 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. |
| Secondary | Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage | Baseline up to 6 months | 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. |
| Other | Proinflammatory Cytokine Genotype Status (IL-1beta, IL-8, and TNFalpha Single Nucleotide Polymorphisms) | At baseline | Will be examined in relation to the outcomes above to further characterize the at-risk population and generate hypotheses for future studies. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Baseline up to 6 months | Only 47 evaluable participants. | pg/mL | MEDIAN |
| SECONDARY | Change in Histology Gastric Score | Baseline up to 6 months | Same populations. A central pathology review of pre-and post-intervention biopsy specimens was performed at the University of Puerto Rico for all study endpoints. Only 47 evaluable participants. | scores on a scale | MEDIAN |
| SECONDARY | Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10) | Baseline up to 6 months | Only 47 evaluable participants. | pg/mL | MEDIAN |
| SECONDARY | Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage | Baseline up to 6 months | Only 47 evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Proinflammatory Cytokine Genotype Status (IL-1beta, IL-8, and TNFalpha Single Nucleotide Polymorphisms) | At baseline |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Arm I (Curcumin) | Antrum: IL-1beta Difference | 0.0 | Full Range -4.2 to 10.9 | pg/mL |
| Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Arm II (Placebo) | Antrum: IL-1beta Difference | -0.1 | Full Range -5.5 to 4.1 | pg/mL |
| Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Arm I (Curcumin) | Body: IL-1beta Difference | 0.0 | Full Range -5.2 to 4.2 | pg/mL |
| Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa | Arm II (Placebo) | Body: IL-1beta Difference | 0.1 | Full Range -0.8 to 8.6 | pg/mL |
| Change in Histology Gastric Score | Arm I (Curcumin) | Correa Score Difference (Puerto Rico data) central review | 0.0 | Full Range -2.8 to 3.6 | scores on a scale |
| Change in Histology Gastric Score | Arm II (Placebo) | Correa Score Difference (Puerto Rico data) central review | 0.0 | Full Range -3.6 to 2.6 | scores on a scale |
| Change in Histology Gastric Score | Arm I (Curcumin) | Correa Score Difference (UAB data) | 0.0 | Full Range -3.6 to 3.6 | scores on a scale |
| Change in Histology Gastric Score | Arm II (Placebo) | Correa Score Difference (UAB data) | 0.0 | Full Range -3.9 to 3.5 | scores on a scale |
| Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10) | Arm I (Curcumin) | Antrum: TNF-alpha Difference | -0.1 | Full Range -3.8 to 5.7 | pg/mL |
| Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10) | Arm II (Placebo) | Antrum: TNF-alpha Difference | 0.0 | Full Range -1.8 to 8.7 | pg/mL |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Curcumin) | 24 | |
| Overall Study | STARTED | Arm II (Placebo) | 26 | |
| Overall Study | COMPLETED | Arm I (Curcumin) | 23 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 25 | |
| Overall Study | NOT COMPLETED | Arm I (Curcumin) | 1 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 1 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Arm II (Placebo) | 0 | 26 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Arm I (Curcumin) | 1 | 24 | 1 |
| other | Cataract | Eye disorders | Arm II (Placebo) | 0 | 26 | 0 |
| other | Cataract | Eye disorders | Arm I (Curcumin) | 1 | 24 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm II (Placebo) | 1 | 26 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Arm I (Curcumin) | 0 | 24 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Placebo) | 2 | 26 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Curcumin) | 1 | 24 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm II (Placebo) | 1 | 26 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm I (Curcumin) | 0 | 24 | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm II (Placebo) | 0 | 26 |
| Total, all-cause mortality | Arm I (Curcumin) | 0 | 24 |
| Total, other adverse events | Arm II (Placebo) | 14 | 26 |
| Total, other adverse events | Arm I (Curcumin) | 12 | 24 |
| Total, serious adverse events | Arm II (Placebo) | 0 | 26 |
| Total, serious adverse events | Arm I (Curcumin) | 0 | 24 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Curcumin) vs Arm II (Placebo): deaths from any cause | Trial comparisons |
| Arm I (Curcumin) vs Arm II (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02782949
GET https://conductscience.org/api/trials/v1/NCT02782949/results?page=2