Double blind randomized trial of sucralfate vs placebo during radical radiotherapy for head and neck cancers

Background. This study sought to determine whether sucralfate prophylaxis d uring a course of high dose radiation therapy (RT) for head and neck cancer decreases acute side effects. Methods. Patients receiving curative intent RT for advanced head and neck c ancers participated in a single institution double-blind randomized trial c omparing sucralfate to placebo. Patients were stratified according to fract ionation, use of concurrent chemotherapy, Kamofsky performance status (KPS) , age, and pretreatment presence of a feeding gastrostomy. Patients were pr ospectively evaluated during weekly treatment checks, and analyzed with reg ard to time (measured in terms of dose) until development of the following: weight loss, mucositis, pain, nutritional intake, and need for a treatment break. After completion of RT, time until healing was similarly compared. Results. Fifty-two patients received sucralfate and 50 received placebo. Th e mean (+/-SD) prescribed dose was 69 +/- 7 Gy. Sixty-nine patients receive d BID fractionation and 27 received concurrent chemotherapy. No difference was detected in any outcome measure in the direct comparison between the tw o groups. On multivariate analysis, weight loss >5% or >10% occurred more f requently in patients receiving chemotherapy (p < 0.01 and p = 0.05, respec tively). Grade 3 mucositis was more common in patients receiving chemothera py (p = 0.05) or BID fractionation (p = 0.04) or having a poor KPS (p = 0.0 2). interval to healing was not associated with any of the pretreatment- or treatment-related factors. Sucralfate did not result in any additional tox icity. Conclusions. Prophylactic treatment with sucralfate during high-dose head a nd neck RT did not decrease acute treatment side effects. Other modalities should be investigated. (C) 1999 John Wiley & Sons, Inc. Head Neck 21: 760- 766, 1999.