Colorectal AdenomaMIRACOLNCT01948661
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
A study testing Mirtoselect® + Meriva® in people with Colorectal Adenoma and Risk Reduction, run by Ente Ospedaliero Ospedali Galliera at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenoma, Risk Reduction
- What is being tested?
- Mirtoselect® + Meriva®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesItaly
- Study dates
- Mar 2014to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Presence of hyperplastic polyps and/or flat adenomas;
- Subjects with pre-existing colorectal cancer;
- Presence of carcinomatous tissue in adenoma;
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
"Gastroenterologia d'urgenza ed Endoscopia digestiva" Ospedale di Lavagna ASL 4 Chiavarese
Chiavari
S.S. Gastroenterologia Ospedale Villa Scassi, ASL3 Genovese
Genoa
Medical Oncology Ente Ospedaliero Ospedali Galliera
Genova, 16128
Divisione di Prevenzione e Genetica Oncologica, IEO
Milan
About this study
Official title: Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
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.
Read the 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.
- Conditions
- Colorectal Adenoma, Risk Reduction
- Being tested
- Mirtoselect® + Meriva®, Placebo
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtoselect® + Meriva®Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanins+Phospholipidic Curcumin | Experimental | 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 Receives: Dietary Supplement: Mirtoselect® + Meriva® |
| placeboA + placeboB | Placebo comparator | placeboA + placeboB per day for four weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beta Catenin Expression
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
Measured: baseline and 4 weeks
Secondary outcomes (1)
Change in Biomarkes Expression
Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startMar 2014
- Primary completion31 Jan 2019
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Umberto Veronesi, Indena S.p.A
- Responsible party
- Principal investigator, Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea DeCensi, MD, Principal investigator, Medical Oncology Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948661
- Sponsor's protocol ID
- GAL 02
- Acronym
- MIRACOL
- Status last verified
- Oct 2024
- First submitted
- 18 Jan 2013
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
- ClinicalTrials.gov ID
- NCT01948661
- Acronym / sponsor ID
- MIRACOL / GAL 02
- Conditions
- Colorectal Adenoma, Risk Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Collaborators
- Fondazione Umberto Veronesi, Indena S.p.A
- Study start
- Mar 2014 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanins+Phospholipidic Curcumin | Experimental | Dietary Supplement: Mirtoselect® + Meriva®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 | Placebo comparator | Dietary Supplement: PlaceboplaceboA + placeboB per day for four weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- Presence of hyperplastic polyps and/or flat adenomas;
- Subjects with pre-existing colorectal cancer;
- Presence of carcinomatous tissue in adenoma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtoselect® + Meriva® | Dietary supplement | Anthocyanins+Phospholipidic Curcumin |
| Placebo | Dietary supplement | placeboA + placeboB |
Primary outcome
Change in Beta Catenin Expression
Time frame: baseline and 4 weeks
Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue
1 secondary outcome
Change in Biomarkes Expression
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea DeCensi, MD principal investigator
Medical Oncology Ente Ospedaliero Ospedali Galliera
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirtoselect® + Meriva® in people with Colorectal Adenoma and Risk Reduction, run by Ente Ospedaliero Ospedali Galliera at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beta Catenin Expression (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.