Trial reportBritish journal of cancer2026
Compound staphylococcal lysostaphin for oral mucositis prophylaxis in hematopoietic stem cell transplantation recipients: a non-inferiority randomized trial.
Trial report in British journal of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06791746 (Compound Staphylococcal Lysostaphin Versus Chlorhexidine Mouthrinse for the Prophylaxis of Oral Mucositis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation), which is not on this map. Not yet cited in PubMed.
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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
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10 authors.
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Abstract
backgroundChlorhexidine mouthrinse offers a cost-effective approach to preventing oral mucositis (OM) in anti-tumour treatment, yet it might cause tooth discoloration, unpleasant taste, and pain. To compare compound Staphylococcal lysostaphin (CSL) mouthrinse to chlorhexidine mouthrinse in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients.
methodsThis randomised, controlled, non-inferiority clinical trial (NCT06791746) randomised adult patients who were scheduled for myeloablative conditioning and allo-HSCT to receive OM prophylaxis using CSL mouthrinse or chlorhexidine mouthrinse. The primary endpoint was the cumulative incidence of oral mucositis, with a non-inferiority margin of 15%.
resultsAmong 196 participants in the CSL mouthrinse group and 197 in the chlorhexidine mouthrinse group, ninety-four (48.0%) and 105 (53.3%) developed OM, respectively. The absolute risk difference was -5.3% (95% CI: -15.6, 4.7), with a upper limit of 95% CI did not exceed the non-inferiority margin. The average pain score was significantly lower with CSL mouthrinse (0.45 ± 1.06 vs. 0.85 ± 1.39, P = 0.002), supported by the analysis of distribution of pain score (P < 0.001). The time to OM onset and cumulative days with OM were comparable between the two groups (both P > 0.05).
conclusionsCSL mouthrinse had non-inferior prophylactic efficacy in reducing OM occurrence in patients undergoing myeloablative conditioning allo-HSCT compared to chlorhexidine mouthrinse, with less pain intensity.
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