Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma

Risk Reduction Clinical Trial

— MIRACOL  

Official title:

Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01948661
• Other study ID #: GAL 02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Subjects with colorectal adenomatous polyps greater than 1 cm in maximum diameter not suitable to immediate complete removal;

• Normal renal and hepatic function;

• WHO Performance status=0;

Exclusion Criteria:

• Presence of hyperplastic polyps and/or flat adenomas;

• Subjects with pre-existing colorectal cancer;

• Presence of carcinomatous tissue in adenoma;

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Risk Reduction

Intervention

Dietary Supplement:
• Mirtoselect® + Meriva®

• Placebo

Locations

Country	Name	City	State
Italy	ASL 3, Ospedale Villa Scassi, S.C. Gastroenterologia	Genova
Italy	Medical Oncology Ente Ospedaliero Ospedali Galliera	Genova
Italy	ASL4 Chiavarese, Ospedale di Lavagna, SSD Gastroenterologia	Lavagna

Sponsors (3)

Lead Sponsor	Collaborator
Ente Ospedaliero Ospedali Galliera	Fondazione Umberto Veronesi, Indena S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of immunohistochemical expression of beta catenin in normal and adenomatous colonic tissue		baseline and 4 weeks
Secondary	Change of IHC Nuclear Factor-Kß (NFKß), Ki-67 Labeling Index and P53 in normal and adenomatous mucosa.		baseline and 4 weeks