Diagnosis and Treatment of Periodontal Disease in Patients With AML

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04530695
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 57

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML; Acute Myelogenous Leukemia	Other: Scaling and Root Planing	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Nov 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge [Day 28 or discharge date (whichever occurs first)]

Secondary Outcome Measures

1. 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).

2. Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first [Day 28 or discharge date (whichever occurs first)]

3. Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first [Day 28 or discharge date (whichever occurs first)]

4. Incidence of death by day 28 [Day 28 or discharge date (whichever occurs first)]

5. Number of days hospitalized [Upto 8 weeks]

   Hospitalization length

6. Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint) [within 2 days after periodontal examination/treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota

Investigators

• Principal Investigator: Armin Rashidi, MD, PhD, University of Minnesota, Division of Hematology, Oncology and Transplantation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT04530695
• Other Study ID Numbers: 2020LS118
• First Posted: Aug 28, 2020
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Masonic Cancer Center, University of Minnesota: AML; Periodontitis; Blood stream infections
• Additional relevant MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute; Periodontal Diseases

Study Results

No Results Posted as of Aug 5, 2021