Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Recurrent Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
| Xylitol-containing Oral Wipe | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (xylitol dental wipe)
- description
- Patients receive standard chemotherapy containing cytarabine IV on study and receive a xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
- interventionNames
- Other: Best Practice
- Procedure: Biospecimen Collection
- Drug: Cytarabine
- Other: Electronic Health Record Review
- Other: Xylitol-containing Oral Wipe
- type
- ACTIVE_COMPARATOR
- label
- Arm II (non-xylitol dental wipe)
- description
- Patients receive standard chemotherapy containing cytarabine IV on study and receive a non-xylitol dental wipe intraorally BID to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until ANC \>= 100/u/L following nadir. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available