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

Cancer. 1993 Oct 1;72(7):2234-8. doi: 10.1002/1097-0142(19931001)72:7<2234::aid-cncr2820720728>3.0.co;2-n.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cryosurgery / methods*
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives*
  • Humans
  • Leucovorin / administration & dosage
  • Male
  • Middle Aged
  • Stomatitis / chemically induced*
  • Stomatitis / prevention & control*


  • 6-fluorouracil
  • Leucovorin
  • Fluorouracil