Diagnosis and Treatment of Periodontal Disease in Patients With AML

Acute Myelogenous Leukemia Clinical Trial

Official title:

Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04530695
• Other study ID #: 2020LS118
• Status: Withdrawn
• Phase: N/A
• Start date: May 2022
• Est. completion date: November 2026

Study information

• Verified date: February 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Periodontal Diseases

Intervention

Other:
• Scaling and Root Planing
Periodontal treatment by scaling and root planing (SRP), deep cleaning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge		Day 28 or discharge date (whichever occurs first)
Secondary	Incidence of BSI by day 28 of chemotherapy or discharge	Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first).	Day 28 or discharge date (whichever occurs first)
Secondary	Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first		Day 28 or discharge date (whichever occurs first)
Secondary	Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first		Day 28 or discharge date (whichever occurs first)
Secondary	Incidence of death by day 28		Day 28 or discharge date (whichever occurs first)
Secondary	Number of days hospitalized	Hospitalization length	Upto 8 weeks
Secondary	Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)		within 2 days after periodontal examination/treatment