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

W. L. McGinnis, C. L. Loprinzi, S. J. Buskirk, J. A. Sloan, R. G. Drummond, A. R. Frank, T. G. Shanahan, S. P. Kahanic, R. L. Moore, S. E. Schild, S. L. Humphrey

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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 languageEnglish (US)
Pages (from-to)1239-1243
Number of pages5
JournalJournal of Clinical Oncology
Volume15
Issue number3
DOIs
StatePublished - Mar 1997

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

McGinnis, W. L., Loprinzi, C. L., Buskirk, S. J., Sloan, J. A., Drummond, R. G., Frank, A. R., Shanahan, T. G., Kahanic, S. P., Moore, R. L., Schild, S. E., & Humphrey, S. L. (1997). Placebo-controlled trial of sucralfate for inhibiting radiation-induced esophagitis. Journal of Clinical Oncology, 15(3), 1239-1243. https://doi.org/10.1200/JCO.1997.15.3.1239