Diagnosis and Treatment of Periodontal Disease in Patients With AML

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

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.

Study Overview

• Status: Withdrawn
• Conditions: AML; Acute Myelogenous Leukemia
• Intervention / Treatment: Other: Scaling and Root Planing

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armin Rashidi, MD, PhD; Phone Number: 612-625-1110; Email: arashidi@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Deep Cleaning; participants with periodontitis will undergo treatment by scaling and root planing (SRP)	Other: Scaling and Root Planing; Periodontal treatment by scaling and root planing (SRP), deep cleaning; Other Names: SRP
No Intervention: Arm B: No cleaning; participants with periodontitis will undergo no periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge	Day 28 or discharge date (whichever occurs first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 death by day 28		Day 28 or discharge date (whichever occurs first)
Number of days hospitalized	Hospitalization length	Upto 8 weeks
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)		within 2 days after periodontal examination/treatment

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): November 1, 2026
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: AML; Periodontitis; Blood stream infections
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Stomatognathic Diseases; Mouth Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Periodontal Diseases
• Other Study ID Numbers: 2020LS118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No