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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionGiven standard chemotherapy
Biospecimen Collection
Procedure/SurgeryUndergo saliva sample collection
Cytarabine
DrugGiven IV
Electronic Health Record Review
Other interventionAncillary studies
Placebo Administration
DrugGiven intraorally
Xylitol-containing Oral Wipe
Other interventionGiven intraorally
Treatment groups
556 Participants
are divided into 2 treatment groupsGroup A: Arm I (xylitol dental wipe)Experimental treatment 5 interventions
Group B: Arm II (non-xylitol dental wipe)Active comparator 5 interventions
Trial outcomes
Primary outcomes
1
Number of bloodstream infections (BSI) from oral flora
Will report the estimated oral organism BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of oral organism BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
Time frame
Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on studySecondary outcomes
1
Number of BSI from any organism
Will report the estimated BSI incidence rates by arm as number of events per 1000 patient-days. Will also report the incidence rate ratio under a Poisson regression model contrasting incidence rates of BSI for the treatment relative to control arm and the corresponding 95% confidence interval.
Time frame
Up to 37 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on studyOther outcomes
1
Severe infection (Common Terminology Criteria for Adverse Events [CTCAE] grade 4 or higher sepsis)
Will report the proportion of patients who experience one or more episodes of febrile neutropenia while on study by arm as well as corresponding 95% confidence intervals.
Time frame
Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study2
Neutropenic fever episodes
Will report the proportion of patients who experience one or more episodes of febrile neutropenia while on study by arm as well as corresponding 95% confidence intervals.
Time frame
Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study3
Severe mucositis (CTCAE grade 3 or higher)
Will report the proportion of patients who experience one or more episode of severe mucositis while on study by arm as well as corresponding 95% confidence intervals.
Time frame
Up to 90 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on study4
Oral microbial layout (as measured by beta diversity using the Bray-Curtis dissimilarity index)
Will report the mean of Bray-Curtis dissimilarity index values by arm, using the final specimen (saliva) collection timepoint for each patient. Will report corresponding 95% confidence intervals.
Time frame
Up to 42 days after the start date of the second cycle of chemotherapy that occurs while the patient is enrolled on studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov