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

Part of paid clinical trials in Oakland, California.

Sponsor
Children's Oncology Group
Study ID
NCT07022678
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Given standard chemotherapy
  • Biospecimen Collection — PROCEDURE
    Undergo saliva sample collection
  • Cytarabine — DRUG
    Given IV
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Placebo Administration — DRUG
    Given intraorally
  • Xylitol-containing Oral Wipe — OTHER
    Given intraorally

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
May 2026
Primary completion
Jan 15, 2032
Completion
Jan 15, 2033

Study Design

Enrollment
556 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (xylitol dental wipe)
    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.
  • Active Comparator: Arm II (non-xylitol dental wipe)
    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.

Primary Outcome Measure

Number of bloodstream infections (BSI) from oral flora [ Time Frame: Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente-OaklandOaklandCalifornia94611
Site Public Contact
[email protected]
877-642-4691
Aarati V. Rao (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oakland, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Kaiser Permanente-Oakland· Oakland, CA

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