556 Participants NeededMy employer runs this trial

Xylitol Dental Wipes for Acute Myeloid Leukemia

Recruiting at 38 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Children's Oncology Group
Must be taking: Chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether xylitol dental wipes can reduce bloodstream infections in children with acute myeloid leukemia (AML) undergoing chemotherapy. Researchers compare xylitol wipes to regular dental wipes to determine if xylitol wipes more effectively prevent bacteria from entering the bloodstream through the mouth. Children with AML who are receiving chemotherapy, have at least one visible tooth, and can avoid xylitol gum or toothpaste during the study may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you should avoid using xylitol-containing gum or toothpaste during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that xylitol, a natural sugar found in fruits and vegetables, is generally safe to use. Studies indicate that xylitol dental wipes effectively reduce bacteria in the mouth, potentially lowering the risk of cavities and gum inflammation.

Regarding safety, earlier studies on xylitol wipes reported very few side effects. Some individuals experienced mild issues like gas or diarrhea, but these were uncommon. Xylitol has also been used safely in other dental products, such as chewing gum, to help prevent tooth decay.

Overall, the evidence suggests that xylitol dental wipes are well-tolerated and offer potential benefits for oral health with few reported side effects.12345

Why do researchers think this study treatment might be promising for AML?

Unlike the standard treatments for acute myeloid leukemia, which primarily involve chemotherapy drugs like cytarabine delivered intravenously, the xylitol dental wipe introduces an innovative delivery method directly targeting oral health. Researchers are excited about this treatment because it uses xylitol, a sugar alcohol known for its ability to reduce harmful bacteria in the mouth, potentially lowering the risk of oral infections during chemotherapy. This approach not only complements traditional chemotherapy but also aims to enhance patient comfort and quality of life by maintaining oral hygiene in a simple, non-invasive manner.

What evidence suggests that xylitol dental wipes could be effective for reducing bloodstream infections in children with acute myeloid leukemia?

Research shows that xylitol dental wipes can significantly reduce the growth of harmful bacteria in the mouth. Studies have found that daily use of xylitol wipes lowers the risk of cavities and reduces dental plaque more effectively than wipes without xylitol. In this trial, some participants will receive xylitol dental wipes, while others will receive non-xylitol dental wipes. For children with acute myeloid leukemia (AML), who face a higher risk of bloodstream infections from mouth bacteria, xylitol wipes might help reduce these infections. The wipes have shown promise in improving oral health and may prevent mouth bacteria from entering the bloodstream. Although more research is needed, early evidence suggests xylitol wipes could reduce infection risks during chemotherapy.12456

Who Is on the Research Team?

JJ

Jennifer J Wilkes

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for children and young adults (ages 1–25) diagnosed with acute myeloid leukemia (AML), who are about to receive chemotherapy that will cause low white blood cell counts for at least a week. Participants must have at least one tooth and agree not to use other xylitol products during the study.

Inclusion Criteria

I agree not to use gum or toothpaste with xylitol during the study.
I (or my guardian) have signed the consent form.
I meet all legal and institutional requirements for participating in human studies.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard chemotherapy with cytarabine and either xylitol or non-xylitol dental wipes for up to 30 days per cycle, for 2 cycles

2 cycles of 30 days each
Daily use of dental wipes

Follow-up

Participants are monitored for safety and effectiveness after treatment, including episodes of febrile neutropenia and severe mucositis

90 days after the start of the last cycle

What Are the Treatments Tested in This Trial?

Interventions

  • Xylitol-containing Oral Wipe

Trial Overview

The study compares dental wipes containing xylitol versus similar wipes without xylitol, to see if using them reduces bloodstream infections in children with AML receiving chemotherapy. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (xylitol dental wipe)Experimental Treatment5 Interventions
Group II: Arm II (non-xylitol dental wipe)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

Citations

Xylitol Dental Wipes for the Reduction of Bloodstream ...

Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.

Effects of Xylitol Wipes on Cariogenic Bacteria and Caries in ...

Daily xylitol-wipe application significantly reduced the caries incidence in young children as compared with wipes without xylitol.

Xylitol Dental Wipes for the Reduction of Bloodstream ...

Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.

Effectiveness of Xylitol Oral Wipes in Prevention of Early ...

Results: Group received xylitol oral wipe +xylitol toothpaste showed maximum reduction in SM count in saliva and increase in pH of saliva in ...

NCT07022678: An ongoing trial by Children's Oncology ...

d Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia Results

Evaluating the Effect of Xylitol Wipes on Cariogenic ...

This clinical study evaluates whether cleaning infants' and toddlers' teeth and gums with xylitol-containing wipes can help reduce oral ...