Salvador, P., Azusano, C., Wang, L., & Howell, D. (2012). A pilot randomized controlled trial of an oral care intervention to reduce mucositis severity in stem cell transplant patients. Journal of Pain and Symptom Management, 44, 64–73.
To assess the effectiveness and feasibility of implementing an oral cryotherapy plus oral care protocol to reduce oral mucositis (OM) severity in patients with multiple myeloma undergoing autologous stem cell transplant (ASCT)
Participants were randomized into an oral cryotherapy study group or a standard oral care control group. Patients in the oral cryotherapy study group received verbal and written instructions on oral cryotherapy plus an oral care protocol in place at the study site. Oral cryotherapy consisted of sucking on ice chips five minutes before, during, and after melphalan administration for a total of 60 minutes. The standard oral care protocol included education regarding oral self care, brushing with Toothette® brushes dipped in sodium bicarbonate, mouth rinsing with sodium bicarbonate mouthwash, and applying moisturizer to lips or the oral cavity. Patients were permitted to floss until their platelet counts fell below 50,000. Patients in the standard oral care control group received only the instructions on the oral care protocol (no cryotherapy). Outcomes were evaluated on days 3, 6, 9, and 12 after stem cell rescue. A research assistant who was blinded to group assignment assessed each participant and recorded the results of the assessment on data collection forms.
The study was conducted at a single-site, inpatient setting in Ontario, Canada.
This was a prospective, pilot, randomized control trial with repeated measures.
Cryotherapy in addition to an oral care protocol (as described above) is likely to be beneficial in reducing the severity of OM as well as decreasing pain and the need for opioid analgesics. In terms of lengths of stay, cryotherapy offered a clinical benefit, although not statistically significant.
Cryotherapy is inexpensive, and the protocol is relatively simple. In conjunction with an oral care protocol, this is a reasonable approach to take. A larger trial would be helpful.