Acute Myelogenous Leukemia, AML
Conditions
Keywords
AML, Periodontitis, Blood stream infections
Brief summary
This is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in Acute Myelogenous Leukemia (AML) patients with asymptomatic periodontitis. Once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (SRP, deep cleaning) (arm A) or receive no periodontal treatment (arm B). We will compare the incidence of Blood Stream Infection (BSI) during chemotherapy between the two arms. Study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.
Detailed description
Bloodstream infection (BSI) is common in patients with acute myeloid leukemia (AML) and causes significant morbidity and mortality. Chemotherapy disrupts oral and intestinal mucosal barriers, facilitating bacterial translocation to the bloodstream. Baseline periodontitis is associated with higher risk of BSI during chemotherapy. In AML patients, since baseline screening and treatment of asymptomatic periodontitis is currently not a standard practice, the researchers are hoping to (i) personalize supportive care according to patient-specific risk factors; (ii) promote an interdisciplinary approach to supportive care by bringing periodontists into the treatment team; (iii) improve quality of life by reducing hospitalization length; (iv) decrease the incidence of re-hospitalization during future phases of treatment; (v) decrease early treatment related mortality (TRM); and (vi) decrease healthcare costs.
Interventions
OTHERScaling and Root Planing
Periodontal treatment by scaling and root planing (SRP), deep cleaning
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Newly diagnosed or relapsed AML * Planned intensive chemotherapy (Any regimen expected to require 3-4 weeks of inpatient stay) * Antibacterial prophylaxis using levofloxacin 500 mg daily * Sufficient time to perform periodontal examination and treatment by day 1 of chemotherapy
Exclusion criteria
* Prior treatment for AML, except hydroxyurea or leukapheresis * ANC \<0.5 x 10\^9/L at the time of enrollment * Post-transfusion platelet count \<50x10\^9/L at the time of enrollment * Unstable for transfer to the School of Dentistry * Fever at the time of enrollment * Documented infection at the time of enrollment * SRP in the last 3 months * Symptomatic periodontal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge | Day 28 or discharge date (whichever occurs first) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first | Day 28 or discharge date (whichever occurs first) | — |
| Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first | Day 28 or discharge date (whichever occurs first) | — |
| Incidence of BSI by day 28 of chemotherapy or discharge | Day 28 or discharge date (whichever occurs first) | Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first). |
| Number of days hospitalized | Upto 8 weeks | Hospitalization length |
| Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint) | within 2 days after periodontal examination/treatment | — |
| Incidence of death by day 28 | Day 28 or discharge date (whichever occurs first) | — |
Outcome results
None listed