Katranci, N., Ovayolu, N., Ovayolu, O., & Sevinc, A. (2012). Evaluation of the effect of cryotherapy in preventing oral mucositis associated with chemotherapy: A randomized controlled trial. European Journal of Oncology Nursing, 16, 339–344.

To assess the effect of oral cryotherapy on development of oral mucositis associated with infusion of fluorouracil (5-FU) with leucovorin

Patients were randomized to cryotherapy or usual care. Prior to randomization, patients completed a study questionnaire, and 60 patients, who had similar characteristics, were selected for randomization. Ice chips were given to patients in the treatment group 5 minutes before and throughout treatment for a total of 30 minutes of continuous use. Mucositis assessment was done on days 7,14, and 21 after chemotherapy.

• The study reported on 60 patients. Ages were not stated.
• The sample was 50% male and 50% female.
• More than 70% in each group did not brush their teeth, and none had gone to a dentist. All were receiving bolus 5-FU treatment. Patients with oral problems at baseline or head and neck cancer were excluded. Gastric and colon cancers were most common in the sample.
• Just more than half (53.3%) of patients were elementary school graduates. 

This was a single-site study conducted in an outpatient setting in Turkey.

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized controlled trial (RCT).

The World Health Organization (WHO) mucositis grading scale was used to assess mucositis severity.

On days 7 and 14, more patients in the experimental group did not have mucositis (p < 0.05). On day 21, patients in the experimental group tended to have lower-grade or grade 0 mucositis, but the difference was not significant.

Findings demonstrated a short-term benefit of cryotherapy in patients receiving 5-FU.

• The sample size was small, with fewer than 100 patients.
• A risk of bias exists because of the lack of blinding and no appropriate attentional control condition.
• The findings are not generalizable as no information about usual care was provided. Investigators selected the group of patients for randomization, which could have biased results. This was a group of patients who did not have any normal oral care, such as routine toothbrushing or ongoing dental prophylaxis. Findings may not be applicable to other groups. No information on oral pain, use of pain medication, or use of other interventions for oral care were included.

Findings suggest that short-term cryotherapy may be beneficial for patients receiving bolus 5-FU; however, longer-term effectiveness may not be seen.