Evaluation of the effect of cryotherapy in preventing oral mucositis associated with chemotherapy - a randomized controlled trial

Eur J Oncol Nurs. 2012 Sep;16(4):339-44. doi: 10.1016/j.ejon.2011.07.008. Epub 2011 Sep 10.


Purpose of the research: The goal of this study was to assess the effect of oral cryotherapy on the development of oral mucositis related to infusion of 5-fluorouracil (5-FU) with leucovorin.

Method: This study, a randomized controlled trial with random assignments to the experimental and control groups, was conducted with cancer patients. The study included 60 patients; 30 patients in the study group were instructed to hold ice cubes in their mouth shortly before, during, and shortly after infusion of 5-FU with leucovorin, the 30 patients in the control group received routine care. Oral mucositis in the patients was evaluated at 7, 14, and 21 days after chemotherapy. For analysis of data, chi-square, Fisher's tests were used; p < 0.05 was accepted as statistically significant.

Results: In the majority of patients receiving cryotherapy, oral mucositis was not observed (Grade 0) at 7 and 14 days. Similarly, incidence of Grades 1, 2, and 3 oral mucositis in the experimental group was quite a bit lower when compared to the control group (p < 0.05). On day 21, no statistically significant difference between the experimental and control groups was determined based on the development of oral mucositis (p > 0.05).

Conclusions: We found that oral cryotherapy has a significant contribution to the protection of oral health by reducing mucositis score according to the WHO mucositis scale, especially on the 7th and 14th days. Nurses' awareness of how cryotherapy can affect patients and options for resolving problems will enable them to provide a higher standard of individualized care.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Agents / adverse effects*
  • Cryotherapy*
  • Female
  • Fluorouracil / adverse effects*
  • Humans
  • Leucovorin / adverse effects*
  • Male
  • Neoplasms / drug therapy
  • Stomatitis / chemically induced
  • Stomatitis / prevention & control*
  • Treatment Outcome


  • Antineoplastic Agents
  • Leucovorin
  • Fluorouracil