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 dose-limiting 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.