Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma (MIRACOL)
|ClinicalTrials.gov Identifier: NCT01948661|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : August 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenoma Risk Reduction||Dietary Supplement: Mirtoselect® + Meriva® Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
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
Dietary Supplement: Mirtoselect® + Meriva®
Placebo Comparator: placeboA + placeboB
placeboA + placeboB per day for four weeks
Dietary Supplement: Placebo
- Change of immunohistochemical expression of beta catenin in normal and adenomatous colonic tissue [ Time Frame: baseline and 4 weeks ]
- Change of IHC Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index and P53 in normal and adenomatous mucosa. [ Time Frame: baseline and 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948661
|ASL 3, Ospedale Villa Scassi, S.C. Gastroenterologia|
|Genova, Italy, 16100|
|Medical Oncology Ente Ospedaliero Ospedali Galliera|
|Genova, Italy, 16128|
|ASL4 Chiavarese, Ospedale di Lavagna, SSD Gastroenterologia|
|Lavagna, Italy, 16033|
|Principal Investigator:||Andrea DeCensi, MD||Medical Oncology Ente Ospedaliero Ospedali Galliera|