Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-25
SponsorChildren's Oncology Group
About this trial
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 criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Best Practice
- Biospecimen Collection
- Cytarabine
- Electronic Health Record Review
- Placebo Administration
- Xylitol-containing Oral Wipe
Treatment groups
556 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov