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

NCT07022678 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Jennifer J Wilkes · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-25
Primary Completion
2032-01-15
Completion
2033-01-15
FDA Drug
Yes

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022678 on ClinicalTrials.gov