RecruitingPhase 3NCT07022678

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

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

Sponsor

Children's Oncology Group

Enrollment

556 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Recurrent 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.

Eligibility

Min Age: 1 YearMax Age: 25 Years

Inclusion Criteria10

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.
Note: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.
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 Criteria6

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.