A pilot randomized controlled trial of an oral care intervention to reduce mucositis severity in stem cell transplant patients.

CONTEXT

Oral mucositis remains a significant problem in autologous stem cell transplantation (ASCT).

OBJECTIVES

This pilot trial assessed the effectiveness of oral cryotherapy plus an oral care protocol in reducing oral mucositis severity in ASCT patients.

METHODS

Patients admitted for ASCT were randomly allocated to either the experimental arm (n=23) or usual care (n=23). All participants received information on principles of good oral hygiene and skills training in oral self-care. Patients in the experimental arm had a 60-minute regimen of oral cryotherapy. The primary outcome of oral mucositis severity and secondary outcomes of mucositis-related pain and functional intake of food and fluids were measured at Days -1, 3, 6, 9, and 12. Length of hospital stay was determined by counting backward from discharge day to admission. Perception of tolerability and acceptability of the 60-minute cryotherapy and frequency of the oral care regimen also were assessed.

RESULTS

Forty-eight patients were recruited at the study site in six months. The overall mean (SE) of oral mucositis severity for the experimental arm was significantly lower than that for the control group: 0.43 (0.12) vs. 1.14 (0.12); P<0.001, on a 0-4 scale. The overall mean (SE) mucositis-related pain score for the experimental arm also was significantly lower than that for the control group: 0.30 (0.23) vs. 1.64 (0.24); P<0.001, on a 0-10 scale.

CONCLUSION

Oral cryotherapy plus an oral care protocol appears to be beneficial in reducing severity of mucositis compared with an oral care protocol alone.