• A Valls, I Pestchen, C Prats, J Pera, G Aragón, M Vidarte, and M Algara.
• Servicio de Radioterapia, Hospital de l'Esperança, Barcelona.
• Med Clin Barcelona. 1999 Nov 27; 113 (18): 681-4.

BackgroundSucralfate 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 MethodOne 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.ResultsThe 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 consumption of loperamide was significantly lower in the sucralfate group (p < 0.001).ConclusionSucralfate is effective in the preparation of acute enteric toxicity induced by pelvic irradiation.

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