Clinical trial NCT01948661: Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
Official title: Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Adenoma
Risk Reduction
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
Collaborators: name: Fondazione Umberto Veronesi
name: Indena S.p.A
First posted: 2013-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change in Beta Catenin Expression
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in Biomarkes Expression
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Chiavari
country: Italy
facility: "Gastroenterologia d'urgenza ed Endoscopia digestiva" Ospedale di Lavagna ASL 4 Chiavarese
city: Genoa
country: Italy
facility: S.S. Gastroenterologia Ospedale Villa Scassi, ASL3 Genovese
city: Genova
country: Italy
facility: Medical Oncology Ente Ospedaliero Ospedali Galliera
city: Milan
country: Italy
facility: Divisione di Prevenzione e Genetica Oncologica, IEO
Study officials:
affiliation: Medical Oncology Ente Ospedaliero Ospedali Galliera
name: Andrea DeCensi, MD
role: PRINCIPAL_INVESTIGATOR
References: