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

Zhejiang University

Status and phase: Completed; Phase 3

Conditions: Stem Cell Transplant Complications; Oral Mucositis

Treatments: Drug: chlorhexidine mouthrinse; Drug: compound Staphylococcal lysostaphin mouthrinse

Study type: Interventional

Funder types: Other

Identifiers

NCT06791746

2019.1114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

compound Staphylococcal lysostaphin mouthrinse

Experimental group

Description:

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.

Treatment:

Drug: compound Staphylococcal lysostaphin mouthrinse

chlorhexidine mouthrinse

Active Comparator group

Description:

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

Treatment:

Drug: chlorhexidine mouthrinse