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

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.

Description

Eligibility

Age range

1–25 years

Sex

All

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

Location