Cheng, K.K., Chang, A.M., & Yuen, M.P. (2004). Prevention of oral mucositis in pediatric patients treated with chemotherapy: A randomized crossover trial comparing two protocols of oral care. European Journal of Cancer, 40, 1208–1216.

DOI Link

Study Purpose

To compare two oral care protocols with children receiving chemotherapy using either benzydamine or chlorhexidine oral rinses

Intervention Characteristics/Basic Study Process

Patients used each mouthwash for three weeks and then crossed over. Patients also used a standard mouthcare protocol consisting of toothbrushing using the Bass method and mouth rinsing with either of the allocated rinses in the early morning and at bedtime, normal saline rinsing within 30 minutes of meals, and normal saline rinsing every 4 hours in the first and third week and every 2 hours in the second week after chemotherapy. Patients were instructed in using a ballooning and sucking motion of the cheeks for 30 seconds without swallowing. Researchers provided reinforcement practice sessions every week and a cartoon reminder.

Sample Characteristics

  • The study reported on 40 patients.
  • Patients had a median age of 10.3 years with a range of 6–17 years.
  • Patients had solid and hematologic tumors.

Setting

The study was conducted from April 2000 to April 2001.

Study Design

This was a prospective randomized, non-blinded, two-period crossover study with continual sequential analysis.

Measurement Instruments/Methods

  • Patient diaries were used. Researchers checked the remainder of rinse weekly to assess compliance.
  • Parents and children were interviewed at each assessment about oral performance. The nurse or investigator assessed patients two times per week.
  • Eilers' Oral Assessment Guide (OAG) was used with minor modifications. Interrelater reliability was established.

Results

  • A total of 34 participants completed the two protocols.
  • No significant differences were found in patients' mean area under the curve (AUC) or oral mucositis according to order of protocols (t = 1.31, p > 0.05). No carry-over effect was found from initial oral care protocol.
  • Fewer patients receiving chlorhexidin developed ulcerative lesions (27% versus 59%).
  • A statistically significant reduction in ulcerative lesions was found using AUC (p < 0.05) and severity of mucositis (p < 0.05) in children on the chlorhexidine protocol.

Conclusions

This study did not demonstrate the superiority of the oral rinses over oral care.

Limitations

  • The study used a crossover methodology for control.
  • The sample size was small.
  • The study was not blinded.
  • The study involved a wide age range.
  • Patients were receiving a variety of chemotherapy protocols.
  • Patients continued systematic oral care along with the protocol.
  • Results may not apply to adult populations.