Panahi, Y., Ala, S., Saeedi, M., Okhovatian, A., Bazzaz, N., & Naghizadeh, M. (2010). Allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositis. European Journal of Cancer Care, 19(3), 308–312.

To prepare and evaluate an allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositis  

Allopurinol mouthwash (1 mg/ml) or placebo was administered 1, 2, and 3 hours after chemotherapy and three consecutive nights for 30 seconds. Patients were instructed to neither wash their mouths nor to eat and drink for 15 minutes afterward.

• The study reported on 30 patients, with a mean age of 56.9 years (SD = 10.3 years) for the allopurinol group and 49.5 years (SD = 13.8 years) for the placebo group.
• The percentage of males was not mentioned in the study. The allopurinol group was 60% female and the placebo group was 66.7% female.
• Cancer diagnoses were breast (n = 13), colon (n = 12), rectum (n = 2), gastric (n = 3), pancreas (n = 2), and esophageal (n = 1).
• All patients with malignant disorders, who were going to receive 5-FU-containing chemotherapy in the outpatient setting, were analyzed.

This was a single-site, outpatient study conducted in a clinic in Sari, Iran.

• All patients were undergoing the active treatment phase of care.
• The study has clinical applicability for end of life and palliative care, elderly care, late effects and survivorship.

This was a placebo-controlled, double-blinded, randomized clinical trial.

An independent physician completed questionnaires consisting of demographic parameters, medical status, quality-of-life survey, and mucosal injury scoring table (based on World Health Organization [WHO] scales for mucositis).

• In the allopurinol arm, 11 of 15 patients (73.3%) did not have mucositis, four (26.6%) had grade 1 (mild), and none had mucositis at a higher grade.
• In the placebo arm, 8 of 15 patients (53.3%) showed no mucositis, five (33.3%) had grade 1, and two (13.3%) developed grade 2 mucositis.

No significant differences were found between the groups with regard to occurrence and severity of mucositis.

• The sample size was small with fewer than 30 patients.
• The time period for treatment and follow up was very short.
• The rationale for timing of the intervention was not  clear.
• Substantial differences existed between groups in the type of chemotherapy given, which would be likely to affect mucositis development.
• No information was provided regarding patient compliance with the protocol for oral rinsing.
• The study was not blinded.

Because of compliance issues with the mouth rinse regimen, low concentration of the allopurinol in the rinse, and a small sample size, the treatment was deemed ineffective in prevention and severity of mucositis. Further studies are needed once the limitations are removed.