DOES SUCRALFATE REDUCE THE ACUTE SIDE-EFFECTS IN HEAD AND NECK-CANCERTREATED WITH RADIOTHERAPY - A DOUBLE-BLIND RANDOMIZED TRIAL

Background and purpose: We evaluated sucralfate, well-known in the tre atment of gastric ulcers, in relation to its possible reduction of rad iation-induced acute complications in the treatment of head and neck c ancers. Materials and methods: One hundred two patients were randomize d in a double-blind placebo-controlled prospective setting. All patien ts were treated to a minimum dose of 55 Gy in 5 weeks. Oral intake of sucralfate was started at the beginning of radiotherapy and continued during the whole treatment at a dose of 1 g six times a day. All patie nts were scored according to a scoring system developed in our departm ent. Weight was checked once a week. Results: Comparing the time cours e of the mean scores for subjective intolerance, mucositis, dysphagia, dermatitis and nausea, no statistically significant differences betwe en the two treatment arms (sucralfate, n = 38; placebo, n = 45) were o bserved. The mean weight loss in the sucralfate arm was 1.6 +/- 3.4 kg while it was 1.3 +/- 2.0 kg in the placebo arm. Apart from gastrointe stinal upset, the administration of sucralfate did not cause any side- effects. Conclusion: This trial produced no clinical evidence indicati ng that the oral intake of sucralfate reduces the acute radiation-indu ced side-effects. Therefore, we do not recommend the prophylactic use of sucralfate in patients with head and neck cancer treated by radioth erapy. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.