Abstract

Title:

Prevention of oral mucositis in paediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash.

Rationale

One of the most debilitating complications of chemotherapy is oral Stomatositis. It occurs in up to 52-80% of children undergoing chemotherapy. Standard oral hygiene includes several mouthwashes that may be chosen for prophylactic and therapeutic use. However, there are only a few studies which compare their efficacy in Paediatric acute lymphoblastic Leukemia (ALL). A consensus protocol regarding prophylaxis and treatment of oral Mucositis is needed for this population of patients.

Objectives

General

To compare the efficacy of 0.12% Chlorohexidine Gluconate and 1% Povidone Iodine mouthwash in the prevention of Oral lesions in children with ALL receiving Chemotherapy.

Specific

1.To determine the demographic and clinical data of the participants as to: a) sex b) age c) type of leukemia d) phase of chemotherapy 2. To determine the effect of 0.12% chlorhexidine gluconate mouthwash and 1% povidone iodine mouthwash in the prevention and treatment of oral lesions in acute lymphoblastic leukemic children receiving chemotherapy as to: a) incidence b) severity of oral lesions c) duration of symptoms 3. To determine any side effects or complications of using either mouthwash.

Study Design

Prospective, randomized controlled, non-blinded, two period cross-over trial

Subjects

Children between 6 and 18 years old diagnosed with ALL who are undergoing Induction, Consolidation, or Reinduction chemotherapy at USTH-BCI from August 2013 to December 2014

Methodology

The study was conducted at the University of Santo Tomas Hospital and Benavides Cancer Institute (USTH-BCI). Twenty-one eligible children ages 6 to 18 years diagnosed with ALL who are undergoing chemotherapy were divided into two groups. Group 1 was instructed to rinse with 10 mL of 0.12% chlorhexidine gluconate mouthwash twice daily, and Group 2 with 10 mL of 1% povidone iodine mouthwash twice daily, for 14 days or until lesions healed if present at the 14^th day of study. Alkaline saline mouthrinse was used by the subjects during the 2 week ‘washout’ time between the two periods of study. The two groups then switched mouthrinses during the second study period. The occurrence of ulcerative lesions and severity of mucositis were measured at baseline and twice weekly of each study period, using the Oral Mucositis Assessment Scale (OMAS) and World Health Organization (WHO) Grading Scale. Statistical analysis includes descriptive statistics using percentage, mean, and standard deviation, frequencies, and percentages. Generalized linear models for testing treatment difference on mean WHO and OMAS scores. Paired t-test was used to test for difference in mean duration. McNemar’s test was used to test for difference in incidence of OM between the two treatments.

Results

Four (19%) subjects experienced mucositis while using 0.12% chlorehexidine mouthwash, while 2 (9.5%) developed mucositis while using 1% povidone iodine mouthwash. Chlorhexidine gluconate mouthwash has a higher mean score than 1% povidone iodine mouthwash on both dependent variables (WHO and OMAS scores), which means that 1% povidone iodine mouthwash has more beneficial effect. The mean duration of mucositis while using chlorhexidine is 9.5 days (3-16 days) while for povidone iodine, 6 days (3-9 days). If we base our conclusion on the 95% confidence interval of the treatment difference and the p-value (<0.05), the differences are not statistically significant. No side effects or complications were observed with the use of either mouthwash.

Conclusion

Both 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash have similar effects in the prophylaxis and treatment of oral mucositis for pediatric patients with acute lymphoblastic leukemia. Either mouthwash may be recommended in a consensus protocol for oral mouth care in this subset of patients during chemotherapy.

Keywords: Chemotherapy; Paediatric Patients; Acute Lymphoblastic Leukaemia; Diseases