Compound Staphylococcal Lysostaphin Vs. Chlorhexidine Mouthrinse for Oral Mucositis in Patients Undergoing Allo-HSCT

Compound Staphylococcal Lysostaphin Versus Chlorhexidine Mouthrinse for the Prophylaxis of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Randomized, Controlled, Non-inferiority Clinical Tria

Oral mucositis (OM) is a common complication in patients receiving myeloablative conditioning allogeneic hematopoietic stem cell transplantation (allo-HSCT). Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM, yet its use is hampered by issues like tooth discoloration, unpleasant taste, and pain on ulcerated surfaces, leading to reduced patient compliance. This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis; Stem Cell Transplant Complications
• Intervention / Treatment: Drug: compound Staphylococcal lysostaphin mouthrinse; Drug: chlorhexidine mouthrinse

Detailed Description

This study aims to demonstrate the non-inferior efficacy of a compound Staphylococcal lysostaphin mouthrinse (Xinjingjie Mouthrinse®) to that of chlorhexidine mouthrinse in reducing OM occurrence in patients receiving myeloablative conditioning allo-HSCT. It also seeks to observe patient treatment adherence and pain, so as to provide evidence for the appropriate OM prevention and management measures in clinical practice. This randomized, controlled, non-inferiority clinical trial was conducted at the Bone Marrow Transplant Center, the First Affiliated Hospital of Medical College, Zhejiang University from January 2020 to December 2021.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Bone marrow transplantation center, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with malignant hematological diseases who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) from fully matched sibling donors, unrelated donors, or haploidentical related donors.
• The conditioning regimen is myeloablative, specifically the BUCY regimen (comprising cytarabine, busulfan, and cyclophosphamide), with methotrexate used for graft-versus-host disease (GVHD) prophylaxis. The dosage of cytarabine is ≥4.0g/m²/day, busulfan is ≥3.2mg/m²/day, and cyclophosphamide is ≥1.8g/m²/day.
• There are no restrictions on age or gender.
• Patients voluntarily agree to participate in this trial.

Exclusion Criteria:

• Patients with an expected survival time of less than one month;
• Patients who have already developed oral mucositis (OM) prior to conditioning;
• Patients undergoing autologous stem cell transplantation;
• Patients receiving a non-myeloablative conditioning regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: compound Staphylococcal lysostaphin mouthrinse; Patients in the compound Staphylococcal lysostaphin mouthrinse group received OM prophylaxis by sequential gargling with 15 ml of sodium bicarbonate mouthrinse and 15 ml of compound Staphylococcal lysostaphin mouthrinse.	Drug: compound Staphylococcal lysostaphin mouthrinse; Lysostaphin is a proteolytic enzyme produced by a specific species of Staphylococcus, uniquely capable of cleaving the cross-linking pentaglycine bridges within the cell walls of Staphylococcus aureus.
Active Comparator: chlorhexidine mouthrinse; The chlorhexidine mouthrinse group followed the same protocol using 15 ml of sodium bicarbonate mouthrinse and 15 ml of chlorhexidine mouthrinse.	Drug: chlorhexidine mouthrinse; Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative incidence of oral mucositis	Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of oral mucositis	The severity of OM was assessed according to the WHO grading criteria.	Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the onset time of oral mucositis		Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
oral pain	Oral pain was evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher numbers indicating greater pain intensity.	Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
compliance with mouth rinsing	Compliance was measured by the average daily frequency of mouthrinse use.	Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
the number of days new analgesics are used due to OM		Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
time to neutrophil engraftment	Neutrophil engraftment was defined as three consecutive days with a neutrophil count >0.5×10e9/L.	Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Mucositis; Stomatitis; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Chlorhexidine; Lysostaphin
• Other Study ID Numbers: 2019.1114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No