Clinical trial NCT04530695: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: AML
Acute Myelogenous Leukemia
Keywords: AML
Periodontitis
Blood stream infections
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
timeFrame: Day 28 or discharge date (whichever occurs first)
Secondary outcomes:
measure: Incidence of BSI by day 28 of chemotherapy or discharge
timeFrame: Day 28 or discharge date (whichever occurs first)
measure: Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first
timeFrame: Day 28 or discharge date (whichever occurs first)
measure: Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
timeFrame: Day 28 or discharge date (whichever occurs first)
measure: Incidence of death by day 28
timeFrame: Day 28 or discharge date (whichever occurs first)
measure: Number of days hospitalized
timeFrame: Upto 8 weeks
measure: Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
timeFrame: within 2 days after periodontal examination/treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota, Division of Hematology, Oncology and Transplantation
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: