Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma

Not Applicable

Completed

Conditions: Colorectal Adenoma
Risk Reduction

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Mirtoselect® + Meriva®

Registration Number: NCT01948661

Lead Sponsor: Ente Ospedaliero Ospedali Galliera

Brief Summary: 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.

Detailed Description: 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Presence of hyperplastic polyps and/or flat adenomas;
Subjects with pre-existing colorectal cancer;
Presence of carcinomatous tissue in adenoma;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placeboA + placeboB	Placebo	placeboA + placeboB per day for four weeks
Anthocyanins+Phospholipidic Curcumin	Mirtoselect® + Meriva®	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

Primary Outcome Measures

Name	Time	Method
Change in Beta Catenin Expression	baseline and 4 weeks	Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue

Secondary Outcome Measures

Name	Time	Method
Change in Biomarkes Expression	baseline and 4 weeks	Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia

Trial Locations

Locations (4): "Gastroenterologia d'urgenza ed Endoscopia digestiva" Ospedale di Lavagna ASL 4 Chiavarese
🇮🇹
Chiavari, Italy
S.S. Gastroenterologia Ospedale Villa Scassi, ASL3 Genovese
🇮🇹
Genoa, Italy
Divisione di Prevenzione e Genetica Oncologica, IEO
🇮🇹
Milan, Italy
Medical Oncology Ente Ospedaliero Ospedali Galliera
🇮🇹
Genova, Italy