[Multicenter double-blind clinical trial comparing sucralfate vs placebo in the prevention of diarrhea secondary to pelvic irradiation].

Background: Sucralfate has been used in the prophylaxis of acute enteric toxicity induced by radiation therapy of pelvic organs. The aim of the study was to demonstrate the efficacy of sucralfate in the prevention of the acute enteric toxicity induced by pelvic irradiation in cancer patients, compared with placebo, in a multicentric double-blind randomised clinical trial.

Patients And Method: One hundred and twenty patients, with a localised pelvic cancer, 18 to 80 years old, with a Karnofsky index of 80% or more, and "normal" defecation habits (3-10 defecations/week), undergoing whole pelvic irradiation, were included.