Nikoletti, S., Hyde, S., Shaw, T., Myers, H., & Kristjanson, L.J. (2005). Comparison of plain ice and flavored ice for preventing oral mucositis associated with the use of 5-fluorouracil. Journal of Clinical Nursing, 14, 750–753.

DOI Link

Study Purpose

To evaluate the use of plain ice, flavored ice, and standard care in the management of oral mucositis

Intervention Characteristics/Basic Study Process

Patients receiving 5-fluorouracil (5-FU) were randomized to receive standard care plus plain ice, standard care plus flavored ice, or standard care alone. Standard care alone consisted of mouthwashes of plain or salty water four times daily plus use of a soft toothbrush and nonabrasive toothpaste. Patients who were assigned to one of the cryotherapy arms were instructed to swirl the ice around the mouth for five minutes prior to, five minutes during, and 20 minutes after the injection. Patients who used plain ice were instructed to do so three times daily. Flavored ice was in the form of a purchased product called \"icy poles.\" Nurses assessed mucositis prior to each chemotherapy cycle and 15 days after each intervention. The sequencing of the interventions was random.

Sample Characteristics

  • The study reported on 79 patients across three cycles of chemotherapy.
  • The majority of patients were male (67%) and had colorectal cancer (92%).

Setting

The study was conducted in an outpatient, chemotherapy, acute care setting at a teaching hospital in Australia.

Study Design

This was a randomized, controlled, crossover trial.

Measurement Instruments/Methods

  • Investigators used an Oral Assessment Guide (OAG) and the Western Consortium Cancer Nursing Research (WCCNR) scale to assess mucositis.
  • A patient questionnaire was used to gather information regarding comfort, satisfaction, and factors affecting compliance.

Results

  • Data analysis of 67 patients were provided as 12 patients were unable to complete the first intervention.
  • The reported odds ratio (odds of symptoms increasing versus not increasing) were as follows.
    • Standard care versus ice: OAG 3.26, p = 0.002; WCCNR 3.23, p = 0.021
    • Standard care versus flavored ice: OAG 3.50, p = 0.003; WCCNR 4.00, p = 0.012
    • Ice versus flavored ice OAG 1.07, p = 0.872; WCCNR 1.20, p = 0.774
    • Leucovorin versus no leucovorin: 4.46, p = 0.050
  • Pain scores were only available for analysis on 28 data sets because of incomplete data. Ice chips were found to be more effective than standard care in reducing pain (p = 0.009). Flavored ice did not differ from either of the other two treatments (p = 0.152, p = 0.581).
  • The taste of the flavored ice and the time required to complete either form of oral cryotherapy were the two main concerns.

Conclusions

  • Both forms of cryotherapy were effective in reducing the severity of oral mucositis after each cycle.
  • The use of leucovorin appeared to increase the odds of patients experiencing mucositis at least fourfold.
  • Use of crossover design is a strength of this study.

Limitations

  • The sample size was small.
  • Only conducting oral assessment prior to chemotherapy initiation and on day 15 may not have provided a complete picture of the differences across groups.
  • The study was not able to be blinded because of the nature of the intervention.