Abstract
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.
Original language | English (US) |
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Pages (from-to) | 1239-1243 |
Number of pages | 5 |
Journal | Journal of Clinical Oncology |
Volume | 15 |
Issue number | 3 |
DOIs | |
State | Published - Mar 1997 |
ASJC Scopus subject areas
- Oncology
- Cancer Research