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

Primary Purpose

Colorectal Adenomas

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

antioxidants

placebo

About this trial

This is an interventional prevention trial for Colorectal Adenomas focused on measuring chemoprevention, colorectal cancer, metachronous adenoma, randomized trial

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

antioxidants

Sugar pill

Arm Description

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]

placebo had an identical appearance as intervention

Outcomes

Primary Outcome Measures

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations

Secondary Outcome Measures

Full Information

NCT ID

NCT01437826

First Posted

September 14, 2011

Last Updated

September 19, 2011

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Collaborators

LILT (Italian league against cancer)

1. Study Identification

Unique Protocol Identification Number

NCT01437826

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Terminated

Why Stopped

50% of eligible patients refused to enter the study

Study Start Date

March 1988 (undefined)

Primary Completion Date

June 1996 (Actual)

Study Completion Date

June 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Collaborators

LILT (Italian league against cancer)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Adenomas

Keywords

chemoprevention, colorectal cancer, metachronous adenoma, randomized trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

411 (Actual)

8. Arms, Groups, and Interventions

Arm Title

antioxidants

Arm Type

Experimental

Arm Description

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]

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

placebo had an identical appearance as intervention

Intervention Type

Drug

Intervention Name(s)

antioxidants

Other Intervention Name(s)

Bio-selenium, Pharma Nord (DK)

Intervention Description

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]

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

placebo was provided by Pharma Nord

Intervention Description

placebo had an identical appearance as intervention

Primary Outcome Measure Information:

Title

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations

Time Frame

five years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luigina A Bonelli, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Genova

ZIP/Postal Code

16132

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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