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

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.

• Authors: 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
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 15 Issue 3 Pg. 1239-43 (Mar 1997) ISSN: 0732-183X [Print] United States
• PMID: 9060568 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Anti-Ulcer Agents
• Sucralfate

Topics

• Administration, Oral
• Aged
• Anti-Ulcer Agents (therapeutic use)
• Esophagitis (drug therapy, prevention & control)
• Female
• Humans
• Male
• Middle Aged
• Radiation Injuries (drug therapy, prevention & control)
• Sucralfate (therapeutic use)