Status:
TERMINATED
Antioxidant Supplement and Reduction of Metachronous Adenomas of the Large Bowel: a Double Blind Randomized Trial
Lead Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborating Sponsors:
LILT (Italian league against cancer)
Conditions:
Colorectal Adenomas
Eligibility:
All Genders
25-75 years
Phase:
PHASE3
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 end...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1996
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT01437826
Start Date
March 1 1988
End Date
June 1 1996
Last Update
September 21 2011
Active Locations (1)
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1
IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy, 16132