AMLNCT04530695
Diagnosis and Treatment of Periodontal Disease in Patients With AML
A study testing Scaling and Root Planing in people with AML and Acute Myelogenous Leukemia, run by Masonic Cancer Center, University of Minnesota.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Acute Myelogenous Leukemia
- What is being tested?
- Scaling and Root Planing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- AML, Acute Myelogenous Leukemia
- Being tested
- Scaling and Root Planing
- Keywords
- AML, Periodontitis, Blood stream infections
- Medical subject headings
- Leukemia, Myeloid, Acute, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningOther
Also called SRP
Periodontal treatment by scaling and root planing (SRP), deep cleaning
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Deep Cleaning | Experimental | participants with periodontitis will undergo treatment by scaling and root planing (SRP) Receives: Other: Scaling and Root Planing |
| Arm B: No cleaning | No intervention | participants with periodontitis will undergo no periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
Measured: Day 28 or discharge date (whichever occurs first)
Secondary outcomes (6)
Incidence of BSI by day 28 of chemotherapy or discharge
Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first).
Measured: Day 28 or discharge date (whichever occurs first)
Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first
Measured: Day 28 or discharge date (whichever occurs first)
Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
Measured: Day 28 or discharge date (whichever occurs first)
Incidence of death by day 28
Measured: Day 28 or discharge date (whichever occurs first)
Number of days hospitalized
Hospitalization length
Measured: Upto 8 weeks
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
Measured: within 2 days after periodontal examination/treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study startMay 2022 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: PI left institution and research was cancelled due to his departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, MD, PhD, Principal investigator, University of Minnesota, Division of Hematology, Oncology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530695
- Sponsor's protocol ID
- 2020LS118
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy
- ClinicalTrials.gov ID
- NCT04530695
- Acronym / sponsor ID
- 2020LS118
- Conditions
- AML, Acute Myelogenous Leukemia
- Keywords
- AML, Periodontitis, Blood stream infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution and research was cancelled due to his departure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Deep Cleaning | Experimental | Other: Scaling and Root Planingparticipants with periodontitis will undergo treatment by scaling and root planing (SRP) |
| Arm B: No cleaning | No intervention | –participants with periodontitis will undergo no periodontal treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlaningAlso: SRPPeriodontal treatment by scaling and root planing (SRP), deep cleaning | Other | Arm A: Deep Cleaning |
Primary outcome
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
Time frame: Day 28 or discharge date (whichever occurs first)
6 secondary outcomes
Incidence of BSI by day 28 of chemotherapy or discharge
Time frame: Day 28 or discharge date (whichever occurs first)
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)
Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
Time frame: Day 28 or discharge date (whichever occurs first)
Incidence of death by day 28
Time frame: Day 28 or discharge date (whichever occurs first)
Number of days hospitalized
Time frame: Upto 8 weeks
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
Time frame: within 2 days after periodontal examination/treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Rashidi, MD, PhD principal investigator
University of Minnesota, Division of Hematology, Oncology and Transplantation
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing in people with AML and Acute Myelogenous Leukemia, run by Masonic Cancer Center, University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge (time frame: Day 28 or discharge date (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.