Children's Oncology Group
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.
PRIMARY OBJECTIVE: I. To compare the incidence rate of bloodstream infections (BSI) (BSI per 1000 patient-days) from oral organisms over 2 cycles of chemotherapy in children with acute myeloid leukemia (AML) randomized to xylitol-containing oral wipes (xylitol dental wipes) versus control wipes. SECONDARY OBJECTIVE: I. To compare the rate of BSI (BSI per 1000 patient-days) from any organism in patients randomized to xylitol dental wipes versus control wipes. EXPLORATORY OBJECTIVES: I. To compare the frequency of severe infection (defined as any infection or infestation falling under Commo…
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.…
Given standard chemotherapy
Undergo saliva sample collection
Given IV
Ancillary studies
Given intraorally
Given intraorally