Trial Outcomes & Findings for Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia (NCT NCT02782949)
NCT ID: NCT02782949
Last Updated: 2025-09-15
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline up to 6 months
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
Arm I (Curcumin)
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.\>
\> Curcumin: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Curcumin)
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.\>
\> Curcumin: Given PO\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.\>
\> Laboratory Biomarker Analysis: Correlative studies\>
\> Placebo Administration: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Baseline characteristics by cohort
| Measure |
Arm I (Curcumin)
n=24 Participants
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Curcumin: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
n=26 Participants
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 10.77 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Honduras
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Gastric mucosal histologic diagnosis
MAG (multifocal atrophic gastritis)
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Gastric mucosal histologic diagnosis
GIM (gastric intestinal metaplasia)
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Gastric mucosal histologic diagnosis
Both (from screening endoscopic gastroduodenoscopy or EGD)
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Only 47 evaluable participants.
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.
Outcome measures
| Measure |
Arm I (Curcumin)
n=22 Participants
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Curcumin: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa
Antrum: IL-1beta Difference
|
0.0 pg/mL
Interval -4.2 to 10.9
|
-0.1 pg/mL
Interval -5.5 to 4.1
|
|
Absolute Change in IL-1beta Cytokine Levels in the Gastric Mucosa
Body: IL-1beta Difference
|
0.0 pg/mL
Interval -5.2 to 4.2
|
0.1 pg/mL
Interval -0.8 to 8.6
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
Arm I (Curcumin)
n=22 Participants
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Curcumin: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Change in Histology Gastric Score
Correa Score Difference (UAB data)
|
0.0 scores on a scale
Interval -3.6 to 3.6
|
0.0 scores on a scale
Interval -3.9 to 3.5
|
|
Change in Histology Gastric Score
Correa Score Difference (Puerto Rico data) central review
|
0.0 scores on a scale
Interval -2.8 to 3.6
|
0.0 scores on a scale
Interval -3.6 to 2.6
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Only 47 evaluable participants.
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.
Outcome measures
| Measure |
Arm I (Curcumin)
n=22 Participants
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Curcumin: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Body: TNF-alpha Difference
|
0.0 pg/mL
Interval -1.8 to 4.6
|
0.0 pg/mL
Interval -8.0 to 12.0
|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Antrum: IL-8 Difference
|
-0.3 pg/mL
Interval -30.7 to 12.4
|
-0.2 pg/mL
Interval -55.4 to 385.2
|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Body: IL-8 Difference
|
0.0 pg/mL
Interval -1.8 to 4.6
|
0.0 pg/mL
Interval -8.0 to 12.0
|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Antrum: TNF-alpha Difference
|
-0.1 pg/mL
Interval -3.8 to 5.7
|
0.0 pg/mL
Interval -1.8 to 8.7
|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Antrum: IP-10 Difference
|
8.0 pg/mL
Interval -135.7 to 285.9
|
14.3 pg/mL
Interval -218.3 to 179.2
|
|
Additional Gastric Mucosal Cytokine/Chemokine Levels (TNFalpha, and IP-10)
Body: IP-10 Difference
|
1.2 pg/mL
Interval -356.5 to 217.0
|
5.2 pg/mL
Interval -132.3 to 157.9
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Only 47 evaluable participants.
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.
Outcome measures
| Measure |
Arm I (Curcumin)
n=22 Participants
Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Curcumin: Given PO
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Quality-of-Life Assessment: Ancillary studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity.
\>
\> Laboratory Biomarker Analysis: Correlative studies
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Baseline · < 1%
|
18 Participants
|
19 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Baseline · 1-5%
|
2 Participants
|
4 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Baseline · >5%
|
2 Participants
|
1 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Baseline · Missing
|
0 Participants
|
1 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Month 6 · < 1%
|
19 Participants
|
13 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Month 6 · 1-5%
|
2 Participants
|
10 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Month 6 · >5%
|
1 Participants
|
1 Participants
|
|
Gastric Mucosal Deoxyribonucleic Acid (DNA) Damage
DNA Damage: Month 6 · Missing
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baselineWill be examined in relation to the outcomes above to further characterize the at-risk population and generate hypotheses for future studies.
Outcome measures
Outcome data not reported
Adverse Events
Arm II (Placebo)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm I (Curcumin)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm II (Placebo)
n=26 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
Arm I (Curcumin)
n=24 participants at risk
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Eye disorders
Cataract
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
2/26 • Number of events 2 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3 • Up to 7 months
|
12.5%
3/24 • Number of events 3 • Up to 7 months
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.5%
3/26 • Number of events 3 • Up to 7 months
|
8.3%
2/24 • Number of events 3 • Up to 7 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Ileal obstruction
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Number of events 2 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 3 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/26 • Up to 7 months
|
12.5%
3/24 • Number of events 3 • Up to 7 months
|
|
General disorders
Pain
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Infections and infestations
Bronchial infection
|
7.7%
2/26 • Number of events 2 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Infections and infestations
Upper respiratory infection
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
8.3%
2/24 • Number of events 2 • Up to 7 months
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • Number of events 3 • Up to 7 months
|
12.5%
3/24 • Number of events 3 • Up to 7 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
2/26 • Number of events 2 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
3/26 • Number of events 5 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 3 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Renal and urinary disorders
Renal calculi
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
2/26 • Number of events 2 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.8%
1/26 • Number of events 1 • Up to 7 months
|
0.00%
0/24 • Up to 7 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/26 • Up to 7 months
|
4.2%
1/24 • Number of events 1 • Up to 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60