Multicentric double blind clinical trial comparing sucralfate vs placebo for the prevention of diarrhoea 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. The duration of the study was 7 weeks, with weekly controls. The first week all patients received placebo. In the second week the patients were randomised into two groups: sucralfate (61 patients, 2 g/tid p.o. before meals) and placebo (59 patients). Radiotherapy started at the beginning of the third week and lasted until the end of the study. All patients received 45-50 Gy total dose (1.8-2 Gy/day, 5 days/week) with the "box technique". The main variables were the number of stools per week and the number of loperamide pills per week. RESULTS: The number of stools per week showed no differences between groups. By the contrary in the group intention to treat (120 patients) and per protocol (100 cases) the percentage of diarrhoeal stools per week showed a statistical significance in favour of sucralfate: (p < 0.05) and (p < 0.03) respectively, concerning the evolution of this variable from the baseline (first week) to the end of the pelvic radiotherapy (seventh week). Furthermore, the comsumtion of loperamine was significantly lower in the sucralfate group (p < 0.001) CONCLUSION: Sucralfate is effective in the preparation of acute enteric toxicity induced by pelvic irradiation.