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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stem Cell Transplant Complications Oral Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

compound Staphylococcal lysostaphin mouthrinse

Intervention Type DRUG

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.

chlorhexidine mouthrinse

The chlorhexidine mouthrinse group followed the same protocol using 15 ml of sodium bicarbonate mouthrinse and 15 ml of chlorhexidine mouthrinse.

Group Type ACTIVE_COMPARATOR

chlorhexidine mouthrinse

Intervention Type DRUG

Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.

Interventions

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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.

Intervention Type DRUG

chlorhexidine mouthrinse

Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No