Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia
Purpose
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.
Conditions
- Acute Myeloid Leukemia
- Recurrent Acute Myeloid Leukemia
Eligibility
- Eligible Ages
- Between 1 Year and 25 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The subject, investigators, and site-specific research and clinical staff who are involved with the conduct of the study will remain blinded to the treatment. The presence of a BSI event (either single organism or polymicrobial) will be determined by review of microbiology reports submitted to a central review committee whose members will be blinded to treatment allocation.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (xylitol dental wipe) |
Patients receive standard chemotherapy containing cytarabine IV on study and receive a 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. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study. |
|
|
Active Comparator Arm II (non-xylitol dental wipe) |
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. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study. |
|
Recruiting Locations
Birmingham, Alabama 35233
Little Rock, Arkansas 72202-3591
Site Public Contact
501-364-7373
Madera, California 93636
Oakland, California 94611
Denver, Colorado 80218
Wilmington, Delaware 19803
Fort Myers, Florida 33908
Jacksonville, Florida 32207
Orlando, Florida 32827
Pensacola, Florida 32504
Atlanta, Georgia 30329
Chicago, Illinois 60611
Site Public Contact
773-880-4562
Des Moines, Iowa 50309
Louisville, Kentucky 40202
Scarborough, Maine 04074
Ann Arbor, Michigan 48109
Site Public Contact
800-865-1125
Grand Rapids, Michigan 49503
Kalamazoo, Michigan 49007
Albuquerque, New Mexico 87106
Albany, New York 12208
Site Public Contact
518-262-5513
The Bronx, New York 10467
Fargo, North Dakota 58122
Cleveland, Ohio 44106
Site Public Contact
216-844-5437
Toledo, Ohio 43606
Danville, Pennsylvania 17822
Philadelphia, Pennsylvania 19104
Pittsburgh, Pennsylvania 15224
Knoxville, Tennessee 37916
Site Public Contact
865-541-8266
Nashville, Tennessee 37203
Site Public Contact
615-342-1919
Austin, Texas 78723
Corpus Christi, Texas 78411
Dallas, Texas 75230
Site Public Contact
972-566-5588
Dallas, Texas 75390
Charlottesville, Virginia 22908
Norfolk, Virginia 23507
Spokane, Washington 99204
Green Bay, Wisconsin 54301
Madison, Wisconsin 53792
More Details
- Status
- Recruiting
- Sponsor
- Children's Oncology Group
Study Contact
Detailed Description
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 Common Terminology Criteria for Adverse Events [CTCAE] sepsis grade 4 or 5) in patients randomized to xylitol dental wipes versus control wipes. II. To compare the frequency of fever and neutropenia episodes in patients randomized to xylitol dental wipes versus control wipes. III. To compare the frequency of severe mucositis, using the Children's International Mucositis Evaluation Scale (ChIMES), in patients randomized to xylitol dental wipes versus control wipes in addition to CTCAE grade 3 and above mucositis. IV. To evaluate changes in oral microbial composition in pediatric patients treated with xylitol versus control wipes. OUTLINE: Patients are randomized to 1 of 2 arms. 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. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study. 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. Treatment continues for 2 consecutive cycles of chemotherapy. Additionally, patients may optionally undergo saliva sample collections throughout the study. 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.