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

• Status: Terminated
• Trial end date: 1996-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Collaborator: LILT (Italian league against cancer)
• Treatments: Antioxidants; Retinol palmitate; Selenium; Vitamin A; Vitamins

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