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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00713 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| N01-CN-2012-00042 | |||
| MAY2015-05-01 | Other Identifier | Mayo Clinic in Rochester | |
| MAY2015-05-01 | Other Identifier | DCP | |
| N01CN00042 | U.S. NIH Grant/Contract | View source | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (curcumin) | Experimental | Patients receive curcumin PO BID for 180 days in the absence of unacceptable toxicity. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO BID for 180 days in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia R Cruz-Correa | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional de Occidente | Santa Rosa de Copán | 41101 | Honduras | |||
| University of Puerto Rico |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 13, 2019 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Placebo Administration | Other | Given PO |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| 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. | 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. | Baseline up to 6 months |
| San Juan |
| 00936 |
| Puerto Rico |
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Gastric mucosal histologic diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only 47 evaluable participants. | Posted | Median | Full Range | pg/mL | Baseline up to 6 months |
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| Secondary | 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)
| 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. | Posted | Median | Full Range | scores on a scale | Baseline up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Only 47 evaluable participants. | Posted | Median | Full Range | pg/mL | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Only 47 evaluable participants. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Other Pre-specified | 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. | Not Posted | At baseline | Participants |
Up to 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm II (Placebo) | Quality-of-Life Assessment: Ancillary studies | 0 | 26 | 0 | 26 | 14 | 26 |
| EG001 | Arm I (Curcumin) | Quality-of-Life Assessment: Ancillary studies | 0 | 24 | 0 | 24 | 12 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | CTCAE 4 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE 4 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Ileal obstruction | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE 4 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 4 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE 4 | Systematic Assessment |
| |
| Infections and infestations - Oth spec | Infections and infestations | CTCAE 4 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE 4 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 4 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE 4 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE 4 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE 4 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE 4 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE 4 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 4 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE 4 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE 4 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE 4 | Systematic Assessment |
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| Renal calculi | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE 4 | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE 4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paul J. Limburg | Mayo Clinic | 507-284-2511 | limburg.paul@mayo.edu |
| Jan 24, 2024 |
| Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Puerto Rico |
|
| GIM (gastric intestinal metaplasia) |
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| Both (from screening endoscopic gastroduodenoscopy or EGD) |
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| Units | Counts |
|---|---|
| Participants |
|
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| Counts |
|---|
| Participants |
|
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| >5% |
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| Missing |
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