Prevention of oral mucositis in pediatric patients with acute lymphoblastic leukemia undergoing chemotherapy: a randomized controlled, cross-over trial using 0.12% chlorhexidine gluconate and 1% povidone iodine mouthwash
- Conditions
- oral mucositisleukemiaCancer - Children's - Leukaemia & LymphomaOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12614000158662
- Lead Sponsor
- Amanda Christina C. Dujua, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Children ages of 6 to 18 years old diagnosed with Acute Lymphoblastic Leukemia who are undergoing Induction, Consolidation, or Re-induction chemotherapy (based on the Modified Berlin-Frankfurt-Munster Acute Lymphoblastic Leukemia Protocol) or Induction or Intensification chemotherapy (based on the Children’s Cancer Group Protocol, CCG-1941: Bone Marrow Transplantation versus Prolonged Intensive Chemotherapy for Children with Acute Lymphoblastic Leukemia after an Initial Bone Marrow Relapse) and seeking consult at STUH-BCI, and are capable of tooth-brushing and mouth-rinsing as judged by the principal investigator
Children with oral mucositis or any oral lesion at initial assessment.
Children with the following conditions: hypersensitivity to iodine, hyperthyroidism, mental retardation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method determining whether there is a difference in effect of 0.12% chlorhexidine and 1% povidone iodine mouthrinses that are both accepted as standard of care for oral mucositis in pediatric cancer patients using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale[2 weeks]
- Secondary Outcome Measures
Name Time Method Decrease in severity of oral mucositis, using the Oral Mucositis Assessment Scale and World Health Organization Grading Scale[2 weeks]