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

This study has been terminated.
(50% of eligible patients refused to enter the study)
Sponsor:
Collaborator:
LILT (Italian league against cancer)
Information provided by (Responsible Party):
Luigina Bonelli, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01437826
First received: September 14, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Colorectal Adenomas
 Drug: antioxidants
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations [ Time Frame: five years ] [ Designated as safety issue: No ]

Enrollment: 411
Study Start Date: March 1988
Study Completion Date: June 1996
Primary Completion Date: June 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: placebo was provided by Pharma Nord

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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437826

Locations
Italy
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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: IST-1988
Study First Received: September 14, 2011
Last Updated: September 19, 2011
Health Authority: Italy: AIFA

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
chemoprevention
colorectal cancer
metachronous adenoma
randomized trial

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Antioxidants
Selenium
Tocopherols
Vitamin A
 Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013