Clinical trial NCT06791746: Compound Staphylococcal Lysostaphin Vs. Chlorhexidine Mouthrinse for Oral Mucositis in Patients Undergoing Allo-HSCT
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stem Cell Transplant Complications
Oral Mucositis
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 388
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cumulative incidence of oral mucositis
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
Secondary outcomes:
measure: severity of oral mucositis
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
measure: the onset time of oral mucositis
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
measure: oral pain
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
measure: compliance with mouth rinsing
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
measure: the number of days new analgesics are used due to OM
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
measure: time to neutrophil engraftment
timeFrame: Time from day 0 to the day of neutrophil engraftment (usually within 30 days after transplantation).
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Bone marrow transplantation center, the First Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China
state: Zhejiang
Study officials:
References: