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Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
Sponsor: Children's Oncology Group
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Year - 25 Years
Study Type
INTERVENTIONAL
Enrollment
556
Start Date
2026-05-26
Completion Date
2033-01-15
Last Updated
2026-08-25
Healthy Volunteers
No
Interventions
Best Practice
Given standard chemotherapy
Biospecimen Collection
Undergo saliva sample collection
Cytarabine
Given IV
Electronic Health Record Review
Ancillary studies
Placebo Administration
Given intraorally
Xylitol-containing Oral Wipe
Given intraorally
Locations (36)
Children's Hospital of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Valley Children's Hospital
Madera, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Blank Children's Hospital
Des Moines, Iowa, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Presbyterian Hospital
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States