A randomized clinical trial of two different durations of oral cryotherapy for prevention of 5‐fluorouracil‐related stomatitis

Abstract

Background. The authors previously reported that 30 minutes of oral cryotherapy inhibits 5‐fluorouracil (5‐FU)‐induced stomatitis. The current trial was designed to determine whether a longer duration of cryotherapy would provide additional protection. Methods. This trial involved patients who were receiving their first course of a 5‐FU plus leucovorin chemotherapy regimen, for which stomatitis is a major doselimiting 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. Both cryotherapy groups had similar degrees of mucositis. Conclusion. The authors continue to recommend the use of 30 minutes of oral cryotherapy for patients receiving bolus intensive courses of 5‐FU‐based chemotherapy. Copyright © 1993 American Cancer Society