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Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
Sponsor: Children's Oncology Group
Summary
This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.
Official title: A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
1 Year - 25 Years
Study Type
INTERVENTIONAL
Enrollment
556
Start Date
2026-08-08
Completion Date
2033-01-15
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Best Practice
Given standard chemotherapy
Biospecimen Collection
Undergo saliva sample collection
Cytarabine
Given IV
Electronic Health Record Review
Ancillary studies
Placebo Administration
Given intraorally
Xylitol-containing Oral Wipe
Given intraorally