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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 30 days, 90 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "ARM I: Patients receive standard chemotherapy containing cytarabine intravenously (IV) on study and receive a xylitol dental wipe intraorally twice daily (BID) to the teeth and gums at the start of the chemotherapy cycle and continuing for up to 30 days or until absolute neutrophil count (ANC) \>= 100/u/L following nadir."
  • "ARM II: 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."
  • "After completion of study treatment, patients are followed over the next cycle of chemotherapy or if chemotherapy is complete, for 90 days after the start of the last cycle of chemotherapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether dental wipes with xylitol lower the risk of bloodstream infections compared with wipes without xylitol. Xylitol is a natural sugar found in fruits and vegetables. The study is for children and young adults with acute myeloid leukemia (AML), a blood cancer, who will receive chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 1 to 25 years old when joining.
  • Have AML that is newly diagnosed or has come back, whether or not it has spread outside the bone marrow.
  • Plan to receive at least 2 chemotherapy cycles in a row that lower blood cell counts. Each must include cytarabine given into a vein and be expected to cause very low infection-fighting white blood cells for at least 7 days. Treatment to prepare for a stem cell transplant does not count toward these cycles.
  • Have at least one tooth that is visible or has come through the gums.
  • Agree not to use gum or toothpaste with xylitol during the study treatment.
  • The patient and/or a parent or legal guardian must sign a form agreeing to join.
  • Meet all hospital and government rules for research involving people.

Who can't join

  • Have AML linked to Down syndrome.
  • Had radiation treatment for cancer of the mouth, head, or neck in the past 6 months.
  • Have a known allergy to xylitol.
  • Have a known allergy to grapes or grape flavoring.
  • Are being treated for a bloodstream infection caused by germs from the mouth.
  • The care provider believes the patient cannot use the dental wipes as required.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. 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.

Study sites (39)

AL

AR

CA

CO

DE

FL

GA

IA

IL

  • Lurie Children's Hospital-Chicago · Chicago, IL 60611Site Public Contact · Study contact · 773-880-4562Sara Zarnegar-Lumley · Principal investigatorMore trials in Chicago

KY

ME

MI

ND

NM

NY

OH

PA

TN

  • East Tennessee Childrens Hospital · Knoxville, TN 37916Site Public Contact · Study contact · 865-541-8266Susan E. Spiller · Principal investigatorMore trials in Knoxville
  • The Children's Hospital at TriStar Centennial · Nashville, TN 37203Site Public Contact · Study contact · 615-342-1919Clinton M. Carroll · Principal investigatorMore trials in Nashville

TX

VA

WA

WI