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NOT YET RECRUITING
NCT07022678
PHASE3

Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

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

OTHER

Best Practice

Given standard chemotherapy

PROCEDURE

Biospecimen Collection

Undergo saliva sample collection

DRUG

Cytarabine

Given IV

OTHER

Electronic Health Record Review

Ancillary studies

DRUG

Placebo Administration

Given intraorally

OTHER

Xylitol-containing Oral Wipe

Given intraorally