Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Change in Beta Catenin Expression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Anthocyanins+Phospholipidic Curcumin
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
Intervention: Mirtoselect® + Meriva® (Dietary Supplement)
placeboA + placeboB
placeboA + placeboB per day for four weeks
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Beta Catenin Expression
Time Frame: baseline and 4 weeks
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
Secondary Outcomes
- Change in Biomarkes Expression(baseline and 4 weeks)
Investigators
Andrea DeCensi
Medical Oncology Director
Ente Ospedaliero Ospedali Galliera