A RANDOMIZED CLINICAL-TRIAL OF 2 DIFFERENT DURATIONS OF ORAL CRYOTHERAPY FOR PREVENTION OF 5-FLUOROURACIL RELATED STOMATITIS

Background. The authors previously reported that 30 minutes of oral cr yotherapy inhibits 5-fluorouracil (5-FU)-induced stomatitis. The curre nt trial was designed to determine whether a longer duration of cryoth erapy would provide additional protection. Methods. This trial involve d patients who were receiving their first course of a 5-FU plus leucov orin chemotherapy regimen, for which stomatitis is a major dose-limiti ng toxicity. These patients were randomized to receive either 30 or 60 minutes of oral cryotherapy given at around the same time as the 5-FU therapy. Results. A total of 178 evaluable patients were studied. Bot h cryotherapy groups had similar degrees of mucositis. Conclusion. The authors continue to recommend the use of 30 minutes of oral cryothera py for patients receiving bolus intensive courses of 5-FU-based chemot herapy.