Diagnosis and Treatment of Periodontal Disease in Patients With AML
Primary Purpose
AML, Acute Myelogenous Leukemia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and Root Planing
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring AML, Periodontitis, Blood stream infections
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A: Deep Cleaning
Arm B: No cleaning
Arm Description
participants with periodontitis will undergo treatment by scaling and root planing (SRP)
participants with periodontitis will undergo no periodontal treatment
Outcomes
Primary Outcome Measures
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
Secondary Outcome Measures
Incidence of BSI by day 28 of chemotherapy or discharge
Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first).
Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first
Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
Incidence of death by day 28
Number of days hospitalized
Hospitalization length
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
Full Information
NCT ID
NCT04530695
First Posted
August 24, 2020
Last Updated
February 20, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04530695
Brief Title
Diagnosis and Treatment of Periodontal Disease in Patients With AML
Official Title
Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution and research was cancelled due to his departure
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, Acute Myelogenous Leukemia
Keywords
AML, Periodontitis, Blood stream infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Deep Cleaning
Arm Type
Experimental
Arm Description
participants with periodontitis will undergo treatment by scaling and root planing (SRP)
Arm Title
Arm B: No cleaning
Arm Type
No Intervention
Arm Description
participants with periodontitis will undergo no periodontal treatment
Intervention Type
Other
Intervention Name(s)
Scaling and Root Planing
Other Intervention Name(s)
SRP
Intervention Description
Periodontal treatment by scaling and root planing (SRP), deep cleaning
Primary Outcome Measure Information:
Title
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
Time Frame
Day 28 or discharge date (whichever occurs first)
Secondary Outcome Measure Information:
Title
Incidence of BSI by day 28 of chemotherapy or discharge
Description
Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first).
Time Frame
Day 28 or discharge date (whichever occurs first)
Title
Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first
Time Frame
Day 28 or discharge date (whichever occurs first)
Title
Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
Time Frame
Day 28 or discharge date (whichever occurs first)
Title
Incidence of death by day 28
Time Frame
Day 28 or discharge date (whichever occurs first)
Title
Number of days hospitalized
Description
Hospitalization length
Time Frame
Upto 8 weeks
Title
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
Time Frame
within 2 days after periodontal examination/treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Rashidi, MD, PhD
Organizational Affiliation
University of Minnesota, Division of Hematology, Oncology and Transplantation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Diagnosis and Treatment of Periodontal Disease in Patients With AML
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