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

Sponsor

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

Overall Status

Terminated

CT.gov ID

NCT01437826

Collaborator

LILT (Italian league against cancer) (Other)

411

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Adenomas	Drug: antioxidants Drug: placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

411 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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 Start Date :

Mar 1, 1988

Actual Primary Completion Date :

Jun 1, 1996

Actual Study Completion Date :

Jun 1, 1996

Arms and Interventions

Arm	Intervention/Treatment
Experimental: antioxidants 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 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] Other Names: Bio-selenium, Pharma Nord (DK)
Placebo Comparator: Sugar pill placebo had an identical appearance as intervention	Drug: placebo placebo had an identical appearance as intervention Other Names: placebo was provided by Pharma Nord

Arm

Intervention/Treatment

Experimental: antioxidants

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

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]

Other Names:

Bio-selenium, Pharma Nord (DK)

Placebo Comparator: Sugar pill

placebo had an identical appearance as intervention

Drug: placebo

placebo had an identical appearance as intervention

Other Names:

placebo was provided by Pharma Nord

Outcome Measures

Primary Outcome Measures

occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations [five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro	Genova		Italy	16132

Sponsors and Collaborators

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
LILT (Italian league against cancer)

Investigators

Principal Investigator: Luigina A Bonelli, MD, IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova - Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luigina Bonelli, MD, responsible of the unit of secondary prevention and screening, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

ClinicalTrials.gov Identifier:

NCT01437826

Other Study ID Numbers:

IST-1988

First Posted:

Sep 21, 2011

Last Update Posted:

Sep 21, 2011

Last Verified:

Sep 1, 2011

Keywords provided by Luigina Bonelli, MD, responsible of the unit of secondary prevention and screening, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Additional relevant MeSH terms:

Adenoma

Selenium

Antioxidants

Study Results

No Results Posted as of Sep 21, 2011