Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Flavonoid

Curcumin

Anthocyanidin

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 per day for four weeks

Mirtoselect® + Meriva®

Placebo

Andrea DeCensi, MD

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.

Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma

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

Fondazione Umberto Veronesi

Indena S.p.A

Ente Ospedaliero Ospedali Galliera

Medical Oncology Director

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma	NCT01948661	Colorectal Aden... Risk Reduction	Mirtoselect® + ... Placebo	18 Years - 75 Years	Ente Ospedaliero Ospedali Galliera
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma	NCT01948661	Colorectal Aden... Risk Reduction	Mirtoselect® + ... Placebo	18 Years - 75 Years	Ente Ospedaliero Ospedali Galliera

Spots Global Cancer Trial Database for mirtoselect® + meriva®