Stem Cell Transplant Complications, Oral Mucositis
Conditions
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.
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.
Interventions
DRUGcompound 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.
Chlorhexidine mouthrinse offers a cost-effective prophylactic approach to preventing OM.
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Oral pain was evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher numbers indicating greater pain intensity. |
| severity of oral mucositis | 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. |
| 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 | 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. |
| compliance with mouth rinsing | 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. |
Countries
China
Outcome results
None listed