Colorectal AdenomasPhase 3NCT01437826

Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial

A Phase 3 study testing antioxidants in people with Colorectal Adenomas, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 25 to 75 years
Conditions the study is for: Colorectal Adenomas
What is being tested?: antioxidants
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 411 participants
Where: 1 siteItaly
Study dates: Mar 1988to Jun 1996
Phase: Phase 3
Are there results?: None posted in the registry

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 25 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 25-75 years
at least one histologically confirmed adenoma endoscopically removed from the large bowel resulting in a polyp-free colon-rectum (clean colon).

Who cannot join

polypectomy performed more than 6 months before enrolment in the trial
history of Familial Adenomatous Polyposis
inflammatory bowel disease
adenoma with invasive carcinoma
ten or more adenomas
large sessile adenoma (3 cm or more

Show all 11Show fewer

colorectal resection
invasive cancer at any site
life-threatening and/or chronic heart, liver or kidney diseases
current use of vitamin or calcium supplements
mental disability

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genova, 16132

Other trials in Italy

About this study

Official title: Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial

The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.

Read the detailed description

Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in people aged 60 or more: about one in four of them has at least one adenoma. In time, adenoma could progress to cancer. Even though only a small rate of adenomas will develop into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer is one of the most frequent malignant tumors in the western world. Several epidemiological studies showed that subjects who had low intake and/or low blood levels of selenium were at increased risk of developing colorectal cancer.

Conditions: Colorectal Adenomas
Being tested: antioxidants, placebo
Keywords: chemoprevention, colorectal cancer, metachronous adenoma, randomized trial
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

antioxidantsDrug
Also called Bio-selenium, Pharma Nord (DK)
tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate]
placeboDrug
Also called placebo was provided by Pharma Nord
placebo had an identical appearance as intervention

Study groups in NCT01437826
Study group	Role	What they receive
antioxidants	Experimental	tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate] Receives: Drug: antioxidants
Sugar pill	Placebo comparator	placebo had an identical appearance as intervention Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 1988Jun 1996

First posted21 Sep 2011 (estimated)
Study startMar 1988
Primary completionJun 1996
Study completionJun 1996

Why it stopped: 50% of eligible patients refused to enter the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal AdenomasStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01437826
Sponsor's protocol ID: IST-1988
Status last verified: Sep 2011
First submitted: 14 Sep 2011
Last updated: 21 Sep 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT01437826
Acronym / sponsor ID: IST-1988
Conditions: Colorectal Adenomas
Keywords: chemoprevention, colorectal cancer, metachronous adenoma, randomized trial
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: 50% of eligible patients refused to enter the study
Enrolment: 411 participants (actual)
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
Collaborators: LILT (Italian league against cancer)
Study start: Mar 1988
Primary completion: Jun 1996 (actual)
Study completion: Jun 1996 (actual)
First posted: 21 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
antioxidants	Experimental	Drug: antioxidantstablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate]
Sugar pill	Placebo comparator	Drug: placeboplacebo had an identical appearance as intervention

Who may qualify

Ages: 25 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

age 25-75 years
at least one histologically confirmed adenoma endoscopically removed from the large bowel resulting in a polyp-free colon-rectum (clean colon).

Key exclusion criteria (11 listed)

polypectomy performed more than 6 months before enrolment in the trial
history of Familial Adenomatous Polyposis
inflammatory bowel disease
adenoma with invasive carcinoma
ten or more adenomas

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
antioxidantsAlso: Bio-selenium, Pharma Nord (DK)tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate]	Drug	antioxidants
placeboAlso: placebo was provided by Pharma Nordplacebo had an identical appearance as intervention	Drug	Sugar pill

Primary outcome

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
Time frame: five years

Results and safety

The study was stopped early (reason given: 50% of eligible patients refused to enter the study). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.

Related trials for Colorectal Adenomas

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Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
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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.

Luigina A Bonelli, MD principal investigator

IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 50% of eligible patients refused to enter the study). Results are not available in the source record.

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?

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437826.

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 Sep 2011.