Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
MIRACOL
Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
1 other identifier
interventional
45
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
September 23, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
October 1, 2024
4.9 years
January 18, 2013
February 7, 2024
October 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Beta Catenin Expression
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
baseline and 4 weeks
Secondary Outcomes (1)
Change in Biomarkes Expression
baseline and 4 weeks
Study Arms (2)
Anthocyanins+Phospholipidic Curcumin
EXPERIMENTALMirtoselect ® 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
PLACEBO COMPARATORplaceboA + placeboB per day for four weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Presence of hyperplastic polyps and/or flat adenomas;
- Subjects with pre-existing colorectal cancer;
- Presence of carcinomatous tissue in adenoma;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ente Ospedaliero Ospedali Gallieralead
- Fondazione Umberto Veronesicollaborator
- Indena S.p.Acollaborator
Study Sites (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
Medical Oncology Ente Ospedaliero Ospedali Galliera
Genova, 16128, Italy
Divisione di Prevenzione e Genetica Oncologica, IEO
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea DeCensi
- Organization
- E.O. Ospedali Galliera
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea DeCensi, MD
Medical Oncology Ente Ospedaliero Ospedali Galliera
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncology Director
Study Record Dates
First Submitted
January 18, 2013
First Posted
September 23, 2013
Study Start
March 1, 2014
Primary Completion
January 31, 2019
Study Completion
June 20, 2022
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-10