Oral cooling (cryotherapy), an effective treatment for the prevention of 5-fluorouracil-induced stomatitis

Eur J Cancer B Oral Oncol. 1994 Jul;30B(4):234-6. doi: 10.1016/0964-1955(94)90003-5.


Recently, a randomised study demonstrated the utility of oral cooling (cryotherapy) in the prevention of 5-fluorouracil (5FU)-induced stomatitis. In order to verify these results a confirmatory study, using identical treatment regimen, was initiated. 84 patients treated with a 5-FU-containing regimen were randomised to a control arm or to receive oral cryotherapy. End point evaluation was obtained by a global assessment of the physician's judgement and patients' description of mucositis severity graded 0-4. Mucositis was significantly reduced by cryotherapy considering both the first cycle of therapy (the mean toxicity score for cryotherapy was 0.59 and it was 1.1 for the control group, P < or = 0.05) and all the chemotherapeutic courses (the mean toxicity score for cryotherapy was 0.36 when it was 0.69 for the control group, P < or = 0.05). In conclusion, the present study confirms that cryotherapy can decrease 5FU-induced stomatitis and should be recommended for patients receiving bolus 5FU-containing regimens.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Cryotherapy*
  • Female
  • Fluorouracil / adverse effects*
  • Humans
  • Male
  • Middle Aged
  • Smoking
  • Stomatitis / chemically induced
  • Stomatitis / prevention & control*


  • Fluorouracil