Gandemer, V., Le Deley, M., Dollfus, C., Auvrignon, A., Bonnaure-Mallet, M., Duval, M., … Schmitt, C. (2007). Multicenter randomized trial of chewing gum for preventing oral mucositis in children receiving chemotherapy. Journal of Pediatric Hematology/Oncology, 29, 86–94.

DOI Link

Intervention Characteristics/Basic Study Process

Patients chewed five to six pieces of fluoride-containing, sugar-free gum, sweetened with xylitol per day for 20 minutes per piece from the first day of chemotherapy to three days after course of treatment. Both groups practiced standard oral care, consisting of brushing teeth with a soft toothbrush and rinsing with sodium bicarbonate rinse.

Sample Characteristics

  • The study reported on 145 children ages 5–18 years. The gum group had 73 patients, and the control group had 72 patients.
  • All patients were scheduled to receive chemotherapy associated with at least a 30% rate of grade 3–4 oral mucositis according to the World Health Organization (WHO) oral mucositis grading scale.

Setting

The study was conducted between March 1999 and December 2002.

Study Design

This was a randomized, controlled trial.

Measurement Instruments/Methods

Researchers recorded the WHO grade of mucositis within first 21 days, time to development of grade 3–4 mucositis, incidence of any grade of mucositis, incidence of pain using a 70-point visual analogue scale, number of days of total parenteral nutrition, incidence of abdominal symptoms, and incidence of septicemia.

Results

No significant differences were found between arms for severe mucositis endpoints.

Patients receiving less toxic regimens had a decrease in WHO grade 1–4 oral mucositis of 49% in the gum group and 72% in the control group (p = 0.03).
 

Limitations

  • This study did not achieve adequate sample size according to power analysis.
  • Eight children discontinued using the gum because of nausea.
  • Chlorhexidine and fungizone were widely used in both arms.