Clinical Trial: Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
Brief Summary:
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 complet
Detailed Summary:
Sponsor: Ente Ospedaliero Ospedali Galliera
Current Primary Outcome: Change of immunohistochemical expression of beta catenin in normal and adenomatous colonic tissue [ Time Frame: baseline and 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change of IHC Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index and P53 in normal and adenomatous mucosa. [ Time Frame: baseline and 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Ente Ospedaliero Ospedali Galliera
Dates:
Date Received: January 18, 2013
Date Started: March 2014
Date Completion: September 2015
Last Updated: August 3, 2015
Last Verified: August 2015
