Svanberg, A., Öhrn, K., & Birgegård, G. (2010). Oral cryotherapy reduces mucositis and improves nutrition: A randomised controlled trial. Journal of Clinical Nursing, 19, 2146–2151.

To investigate if oral cryotherapy during myeloablative therapy may influence frequency and severity of mucositis, nutritional status, and infection rate after bone marrow transplant

Patients were randomly assigned to the cryotherapy treatment group or the usual care control group. A stratified randomization technique was used in regard to the type of transplant. Patients in the cryotherapy treatment group were instructed to suck on ice chips or rinse with ice-cold water during chemotherapy administration. The control group followed usual care without cryotherapy.

• The study reported on 78 patients aged 18 years or older.
• The mean age of the cryotherapy treatment group was 49.8 years (SD = 14.4 years), and the mean age of the usual care control group was 54.3 years (SD = 11.0 years).
• The sample was 58% male and 42% female.
• All patients had been diagnosed with hematologic or oncologic malignances. A total of 11 different diagnoses were represented.
• No significant differences existed between the cryotherapy treatment group and the usual care control group regarding age, gender, or tobacco use; the types of conditioning regimens; or the use of total body irradiation.

The study was conducted at a single-site, inpatient setting in Uppsala, Sweden.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for palliative care.

This was a randomized controlled trial.

• Investigators used an Oral Mucositis Assessment Score (OMAS), which was converted into the World Health Organization (WHO) scale.
• Infection rates were assessed based on neutropenic fever and use of IV antibiotics.
• Nutrition was assessed based on rate of total parenteral nutrition (TPN) and serum albumin.

• Fewer patients in the cryotherapy treatment group experienced grade 3–4 oral mucositis (OM) than in the control group (p < 0.05). However, no statistical difference was found in the severity of mucositis in the subgroup of patients receiving unrelated donor bone marrow transplant.
• No significant differences were found in weight loss between the cryotherapy treatment group and the control group.
• Fewer patients in the cryotherapy treatment group needed TPN and the number of days of TPN were fewer than in the control group. However, these differences were not statistically significant.
• The cryotherapy treatment group maintained better serum albumin levels on days 1–6 (p < 0.01) and days 7–13 (p < 0.009). 
• The cryotherapy treatment group had significantly fewer days of hospitalization (p < 0.05) in the subgroup of patients receiving unrelated donor bone marrow transplant.
• No statistical significance was found between groups related to the number of days with fever, number of positive blood cultures, or use of IV antibiotics.

Oral cryotherapy may be helpful in reducing the severity of mucositis, particularly in patients receiving autologous stem cell transplant (ASCT). Decreasing the severity of mucositis may lead to decreases in the need for TPN and better maintenance of serum albumin levels. Limited statistically significant findings were found in this study; however, it supports positive trends that favor cryotherapy use. Larger, prospective trials need to be completed.

• The sample size was small with fewer than 100 patients.
• The investigators did not clearly describe how the OMAS scale translated into the WHO scale.
• The compliance rate for using the oral cryotherapy for the unrelated  bone marrow transplant group was only three out of eight patients or less than half of the time.

Mucositis carries a high symptom burden for patients undergoing stem cell transplant. Cryotherapy may be one way to curb the effects of oral mucositis. However, this study provided no evidence to suggest that cryotherapy is the definitive way to prevent mucositis or to lessen the intensity of mucositis for all patients across the board.