Int. .I. Radiation Oncology Biol. Phys., Vol. 37, No. 2, pp. 275-279, 1997 Copyright 0 1997 Elsevier Science Inc. Printed in the USA. All rights reserved 0360-3016/97 $17.00 + .OO ELSEVIER l Clinical Investigation PI1 SO360-3016(96)00531-7 SUCRALFATE FOR RADIATION MUCOSITIS: RESULTS OF A DOUBLE-BLIND RANDOMIZED TRIAL RUBY MEREDITH, M.D.,PH.D.,* MERLE SALTER, M.D.,* ROBERT KIM, M.D.,* SHARON SPENCER, M.D.,* BURKHARD WEPPELMANN, M.D.,’ BRAD RODU, M.D.,* JUDY SMITH, B.S.* AND JEANETTE LEE, PH.D.’ Departments of *Radiation Oncology, tOra1Pathology, fBiostatistics, University of Alabama at Birmingham Comprehensive Cancer Center,Birmingham, AL Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositisover a popular combination of antacid, diphenhydramine,and viscouslidocaine alone. Methods and Materials: A double-blind study wasconductedin which nurses and pharmacists codedpatient groups and distributed medicationin a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chestsites that included the esophagus were randomized to a standard combinationof antacid, diphenhydramine, and viscous lidocainevs. the same solution plussucralfate. Eligible patients were thosereceiving >40 Gy at 1.8 Gy/fraction, one fraction/day, five fractions/week.Partici- pating patients were stratified betweenchest,small field head and neck, and large field head and neck. The patients subjective evaluation of throat soreness and relief with medicationwas elicited as well as physician observations and smears for Candidiasis screening. Medication was prescribedwhen the patient became symp- tomatic and concomitant use of other locally effective nonstudyagents was not allowed. The ability to eat various consistency of foods wasgraded O-5, with 5 indicating no compromise of ability to ingesta food compared to baseline. Statisticalanalysis included mean+ SDfor food andsoreness scores, pairedt-test, and two-way analyses of variance to evaluateeffectsof site and treatment group on the changes in scores. Results: Over 2 years, 111 patientswere entered.Because some withdrew and othersdid not require medication, results are presented for evaluable patientsin eachcategory. Mild adverse effectsfrom the medication solution (usually mouth discomfort) were reported by <lo% of patients in each treatment group among 106 patients evaluable for toxicity. There was a comparable incidence of mild-moderate mucositis for the two treatmentgroups. Severe mucositis was noted in two patients of the standardmedication group and noneamong patients receiving sucralfate. The groups werecomparable for indicators including degree of soreness, dietary changes, andobjective measures or mucosal irritation or infection. For the headand neck patients there wasa significantworsening in soreness and in the ability to eat in both treatment groups, whereas patients treated to the chest had less nutritional change. Multivariate analysis including control for confoundingfactors did not detect treatment effects for any of the response measures. No patient had occult fungal infection detected by oral pathology evaluationof routine mucosal scrapings. Conclusions: A trend (that was not statistically significant) of less severe radiation mucositis was notedfor patients receiving sucralfatein addition to the combinationof viscous lidocaine, diphenhydramine, and antacid for non- ulcerative radiation mucositis. 0 1997 Elsevier Science Inc. Radiation, Mucositis, Sucralfate. INTRODUCTION Radiation to the head and neck or chest frequently results in symptomatic mucositis. Not only does this contribute to patient discomfort, but it may compromise therapy if symptoms are severe enough to limit nutritional intake and/or force unplanned treatment interruption. Agents that coat the mucous membranes may soothe the irritation and, in reducing friction, may promote recovery. Several re- ports have suggesteda beneficial effect of sucralfate, an ulcer-coating polysaccharide compound, for palliation of radiation and/or chemotherapy related mucositis (1,6, 15, 17). To determine if sucralfate could provide improved symptomatic relief when added to a popular combination Presented at the AmericanSociety for Therapeutic Radiology Acknowledgements-The authors wish to thank SteveBernhard and Oncologyannual conference, Miami, FL, October8, 1995. for pharmaceutical assistance, SheilaSparks, Frances Stanfield, Reprint requests to: Ruby Meredith, M.D., Ph.D., Depart- andAnn Wootenfor nursing services, and Carolyn Maddox for ment of Radiation Oncology, 619 S. 19th St., Birmingham, manuscript preparation. AL 35233. Acceptedfor publication23 October1996. 275