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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
411
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
IRCCS Azienda Ospedale Università San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy
occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
Time frame: five years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.