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Xylitol Dental Wipes for Bloodstream Infection Prevention in Children with AML

This study is looking at whether xylitol dental wipes can help reduce the risk of bloodstream infections in children (ages 1 to 25) with acute myeloid leukemia (AML), a type of blood cancer. Children with AML often receive chemotherapy, which can increase their risk of serious bloodstream infections. Xylitol is a natural sugar found in fruits and vegetables that may limit the growth of harmful bacteria in the mouth. This trial compares xylitol dental wipes to wipes without xylitol to see if they can prevent these infections. The main goal is to see if xylitol wipes reduce the number of bloodstream infections from mouth bacteria during chemotherapy.

Study design
This interventional study plans to enroll 556 participants and compares xylitol-containing oral wipes to control wipes.
What's involved
Participants will undergo saliva sample collection and receive either xylitol or placebo dental wipes, along with standard chemotherapy (Cytarabine).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures bloodstream infections up to 37 days after the start of the second chemotherapy cycle while on study.

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NCT07022678

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

Recruiting
PHASE3Ages 1–25InterventionalSupportive care
Children's Oncology Group
~556 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Best PracticeBiospecimen CollectionCytarabineElectronic Health Record ReviewPlacebo AdministrationXylitol-containing Oral Wipe

At a glance

Recruiting sites
35 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of bloodstream infections (BSI) from oral flora
Measured over Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

Conditions

Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

36 sites across 21 states
Texas4
Florida3
Pennsylvania3
California2
Kentucky2
Michigan2
New York2
Ohio2

Study leadership

  • Jennifer J Wilkes · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Eligibility criteria

Inclusion

Patient must be ≥ 1 year to ≤ 25 years old at enrollment.
Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.
Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:
Contain IV cytarabine (liposomal formulations allowed), and
The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles.
Minimum of one visible or erupted tooth.
Agree to avoid xylitol containing gum or toothpaste during intervention period.
All patients and/or their parents or legal guardians must sign a written informed consent.
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion

Patients with Down syndrome-associated AML.
Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.
Patients with known history of allergy to xylitol.
Patients with known history of allergy to grapes or grape flavoring.
Patients who are actively being treated for an oral organism related blood stream infection.
Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.

What this trial measures

  • Number of bloodstream infections (BSI) from oral floraUp to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study

    Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.