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

Conditions

• Acute Myeloid Leukemia
• Recurrent Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

1 Year - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Given standard chemotherapy
• Biospecimen Collection — PROCEDURE
  Undergo saliva sample collection
• Cytarabine — DRUG
  Given IV
• Electronic Health Record Review — OTHER
  Ancillary studies
• Placebo Administration — DRUG
  Given intraorally
• Xylitol-containing Oral Wipe — OTHER
  Given intraorally

Study Details

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.

Key Dates

First listed

Jun 15, 2025

Start date

May 26, 2026

Status verified

Jul 2026

Primary completion

Jan 15, 2032

Completion

Jan 15, 2033

Study Design

Enrollment

556 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (xylitol dental wipe)
  Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
• Active Comparator: Arm II (non-xylitol dental wipe)
  Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.

Primary Outcome Measure

Number of bloodstream infections (BSI) from oral flora [ Time Frame: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study ]

Locations (28)

Find similar trials in Little Rock, AR

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