Xylitol dental wipes to lower bloodstream infections in kids with AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 trial, children with AML undergoing myelosuppressive chemotherapy are randomized to receive xylitol-containing dental wipes or standard wipes. The goal is to see if xylitol reduces bloodstream infections caused by mouth-dwelling bacteria and fungi during two cycles of treatment. Secondary and exploratory analyses look at overall infection rates, fever with neutropenia, mucositis severity, and changes in oral microbes. The study uses routine chemotherapy (cytarabine) and monitors infections, mucositis, and microbiology as outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Valley Children's Hospital
  Madera, California, United States Recruiting
• Kaiser Permanente-Oakland
  Oakland, California, United States Recruiting
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  Denver, Colorado, United States Recruiting
• Alfred I duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting

Study contacts

• Principal investigator: Jennifer J Wilkes — Children's Oncology Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.