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Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma (MIRACOL)

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ClinicalTrials.gov Identifier: NCT01948661
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
Fondazione Umberto Veronesi
Indena S.p.A
Information provided by (Responsible Party):
Andrea DeCensi, Ente Ospedaliero Ospedali Galliera

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Adenoma Risk Reduction Dietary Supplement: Mirtoselect® + Meriva® Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
Study Start Date : March 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: 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
Dietary Supplement: Mirtoselect® + Meriva®
Placebo Comparator: placeboA + placeboB
placeboA + placeboB per day for four weeks
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Change of immunohistochemical expression of beta catenin in normal and adenomatous colonic tissue [ Time Frame: baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Change of IHC Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index and P53 in normal and adenomatous mucosa. [ Time Frame: baseline and 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948661


Locations
Italy
ASL 3, Ospedale Villa Scassi, S.C. Gastroenterologia
Genova, Italy, 16100
Medical Oncology Ente Ospedaliero Ospedali Galliera
Genova, Italy, 16128
ASL4 Chiavarese, Ospedale di Lavagna, SSD Gastroenterologia
Lavagna, Italy, 16033
Sponsors and Collaborators
Ente Ospedaliero Ospedali Galliera
Fondazione Umberto Veronesi
Indena S.p.A
Investigators
Principal Investigator: Andrea DeCensi, MD Medical Oncology Ente Ospedaliero Ospedali Galliera

Responsible Party: Andrea DeCensi, Medical Oncology Director, Ente Ospedaliero Ospedali Galliera
ClinicalTrials.gov Identifier: NCT01948661     History of Changes
Other Study ID Numbers: GAL 02
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action