BACKGROUND: @entity5418 has been used in the prophylaxis of acute enteric @entity137 induced by radiation therapy of pelvic organs. The aim of the study was to demonstrate the efficacy of @entity5418 in the prevention of the acute enteric @entity137 induced by pelvic irradiation in @entity5 @entity1 , compared with placebo, in a multicentric double-blind randomised clinical trial. @entity1 AND METHOD: One hundred and twenty @entity1 , with a localised pelvic @entity5 , 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 @entity1 received placebo. In the second week the @entity1 were randomised into two groups: @entity5418 (61 @entity1 , 2 g/tid p.o. before meals) and placebo (59 @entity1 ). Radiotherapy started at the beginning of the third week and lasted until the end of the study. All @entity1 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 @entity3062 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 @entity1 ) and per protocol (100 cases) the percentage of diarrhoeal stools per week showed a statistical significance in favour of @entity5418 : (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 @entity3062 was significantly lower in the @entity5418 group (p < 0.001). CONCLUSION: @entity5418 is effective in the preparation of acute enteric @entity137 induced by pelvic irradiation.

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

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity5418 :: ('MESH:D013392', 'Chemical') :: ['sucralfate', 'Sucralfate'] @entity3062 :: ('MESH:D008139', 'Chemical') :: ['loperamide']
@entity5418 :: (MESH:D013392,Chemical) :: ['sucralfate']
