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NCT Number: NCT06791746

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

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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Key information

Conditions

Stem Cell Transplant Complications Mouth Diseases Oral Mucositis Stomatitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

chlorhexidine mouthrinse

Drug

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

Primary outcomes

  1. cumulative incidence of oral mucositis

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

Secondary outcomes

  1. severity of oral mucositis

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

    The severity of OM was assessed according to the WHO grading criteria.

  2. the onset time of oral mucositis

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

  3. oral pain

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

    Oral pain was evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher numbers indicating greater pain intensity.

  4. compliance with mouth rinsing

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

    Compliance was measured by the average daily frequency of mouthrinse use.

  5. the number of days new analgesics are used due to OM

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

  6. time to neutrophil engraftment

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

    Neutrophil engraftment was defined as three consecutive days with a neutrophil count >0.5×10e9/L.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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