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| Name | Class |
|---|---|
| Fondazione Umberto Veronesi | OTHER |
| Indena S.p.A | INDUSTRY |
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It has been shown that curcumin and cyanidin-3-glucoside (C3G) have anticancer effects. In this clinical trial we compare the affect of their combination vs placebo in a four weeks intervention before endoscopic polypectomy.
Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for testing agents with potential cancer prevention.
Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels of parent agent than natural curcumin.
Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the Apc(Min) mouse model.
The investigators hypothesize that the combination of both agents will decrease the expression of proteins involved in colon tumorigenesis relative to placebo.
The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic resection in the target adenoma and the normal rectal mucosa will be the response measures.
The primary response measure is the change of immunohistochemical (IHC) expression of β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and apoptosis by P53 in adenomatous and adjacent normal mucosa.
The study design is a phase II, randomized, double blind, placebo controlled, window of opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo. Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable to immediate complete removal will be enrolled in a 4-week intervention trial before endoscopic polypectomy.
The demonstration of a biological activity of the two agent combination may provide the rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthocyanins+Phospholipidic Curcumin | Experimental | Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days |
|
| placeboA + placeboB | Placebo Comparator | placeboA + placeboB per day for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtoselect® + Meriva® | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beta Catenin Expression | Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Biomarkes Expression | Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia | baseline and 4 weeks |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea DeCensi, MD | Medical Oncology Ente Ospedaliero Ospedali Galliera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Gastroenterologia d'urgenza ed Endoscopia digestiva" Ospedale di Lavagna ASL 4 Chiavarese | Chiavari | Italy | ||||
53 participants were contacted:
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Anthocyanins+Phospholipidic Curcumin | Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days |
| FG001 | Placebo Comparator | placeboA + placeboB per day for four weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Beta Catenin Expression | Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue | Beta-catenin expression according to the treatment arms and the time points in normal tissue and dysplasia | Posted | Mean | Standard Deviation | percentage of positive cells | baseline and 4 weeks |
|
4 weeks
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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 | Experimental Arm | Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea DeCensi | E.O. Ospedali Galliera | 010563 | 4501 | andrea.decensi@galliera.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2016 | Oct 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Dietary Supplement |
|
| S.S. Gastroenterologia Ospedale Villa Scassi, ASL3 Genovese |
| Genoa |
| Italy |
| Medical Oncology Ente Ospedaliero Ospedali Galliera | Genova | 16128 | Italy |
| Divisione di Prevenzione e Genetica Oncologica, IEO | Milan | Italy |
Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Level of Education | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Alcholol Habits | Count of Participants | Participants |
|
| Baseline BMI | Count of Participants | Participants |
|
| Family history of colorectal cancer | Count of Participants | Participants |
|
| Baseline histological type | Count of Participants | Participants |
|
| Baseline Dysplasia grade | Count of Participants | Participants |
|
| # of comorbidity | Median | Inter-Quartile Range | number of comorbidities |
|
| # of concomitant medications | Median | Inter-Quartile Range | number of concomitant medications |
|
|
|
| Secondary | Change in Biomarkes Expression | Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia | Tissue biomarker expression according to the treatment arms and the timepoints in normal tissue and dysplasia | Posted | Mean | Standard Deviation | percentage of positive cells | baseline and 4 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Control Arm | Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die | 0 | 14 | 0 | 14 | 2 | 14 |
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| NFKβ Pre-treatment: Dysplasia |
|
| NFKβ Post-treatment: Dysplasia |
|
| Ki-67 Pre-treatment: Normal tissue |
|
| Ki-67 Post-treatment: Normal tissue |
|
| Ki-67 Pre-treatment: Dysplasia |
|
| Ki-67 Post-treatment: Dysplasia |
|
| P53 Pre-treatment: Normal tissue |
|
| P53 Post-treatment: Normal tissue |
|
| P53 Pre-treatment: Dysplasia |
|
| P53 Post-treatment: Dysplasia |
|