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

NCT06791746 | Completed Phase 3

• 1 other identifier: 2019.1114
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplant Complications; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• cumulative incidence of oral mucositis

  Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

Secondary Outcomes (6)

• severity of oral mucositis

  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

  Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).

• compliance with mouth rinsing

  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).

Study Arms (2)

compound Staphylococcal lysostaphin mouthrinse

EXPERIMENTAL

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

chlorhexidine mouthrinse

ACTIVE COMPARATOR

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

Drug: chlorhexidine mouthrinse

Interventions

compound Staphylococcal lysostaphin mouthrinse 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.

compound Staphylococcal lysostaphin mouthrinse

chlorhexidine mouthrinse DRUG

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

chlorhexidine mouthrinse

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 24, 2025
• Study Start: January 2, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)