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

RecruitingPhase 3Ages 1 Year - 25 YearsAllChildren's Oncology Group
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient must be โ‰ฅ 1 year to โ‰ค 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 โ‰ฅ 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.
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What it tests

  • Best Practice
  • Biospecimen Collection
  • Cytarabine
  • Electronic Health Record Review
  • Placebo Administration
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Where

39 sites
Children's Hospital of Alabama
Birmingham, United States
Arkansas Children's Hospital
Little Rock, United States
Valley Children's Hospital
Madera, United States
Kaiser Permanente-Oakland
Oakland, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, United States
Alfred I duPont Hospital for Children
Wilmington, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, United States

โ€ฆand 31 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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