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

Launched by CHILDREN'S ONCOLOGY GROUP · Jun 6, 2025

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ClinConnect Summary

This clinical trial is studying whether using xylitol dental wipes can help reduce the risk of bloodstream infections in children and young adults (ages 1 to 25) who are being treated for acute myeloid leukemia (AML). AML is a type of cancer that affects the blood and bone marrow, and patients receiving chemotherapy for AML have a higher chance of getting infections, especially from bacteria that can enter the bloodstream through the mouth. Xylitol is a natural sugar found in fruits and vegetables that can help prevent the growth of harmful bacteria in the mouth. This trial will compare xylitol dental wipes to regular dental wipes to see if they make a difference in infection rates.

To be eligible for this trial, participants must be between 1 and 25 years old, have a diagnosis of AML, and be scheduled to receive at least two cycles of chemotherapy that may lower their white blood cell counts for a long period. They should also have at least one visible tooth and agree not to use any other xylitol products during the study. If they join the trial, participants will use the dental wipes as directed and will be monitored closely for any changes in their health. It’s important to note that some children, such as those with specific allergies or certain previous treatments, may not be able to participate. Overall, this study aims to find a simple way to help protect young patients from serious infections during their cancer treatment.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.