Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis

Purpose: To determine whether a sucralfate oral solution can prevent/alleviate radiation-induced esophagitis. Patients and Methods: Patients included on this clinical trial were beginning thoracic radiation therapy to the mediastinum. Following stratification, they were randomized, in a double-blind manner, to receive a sucralfate solution or an identical-appearing placebo solution, Esophagitis was measured by physicians who used standard criteria and also by patients who used short questionnaires completed weekly during the course of the trial. Results: A total of 97 assessable patients were entered onto this clinical trial, During the first 2 weeks of the study, two placebo patients (4%) stopped their study medication, compared with 20 sucralfate patients (40%), This was related to substantially increased incidences of gastrointestinal toxicity (58% of sucralfate patients v 14% of placebo patients; P > .0001), There was no substantial benefit from the sucralfate in terms of esophagitis scores. Conclusion: This oral sucralfate solution does not appear to inhibit radiation-induced esophagitis and is associated with disagreeable gastrointestinal side effects in this patient population. (C) 1997 by American Society of Clinical Oncology.