Based on the results of a single-center phase III Chinese trial, which were published by Liao et al in JAMA Oncology, bacterial decolonization therapy with the antibiotic mupirocin may be an effective and cost-efficient strategy for alleviating severe acute radiation-induced oral mucositis in patients with nasopharyngeal carcinoma.
“Bacterial decolonization therapy reduced the severe acute radiation-induced oral mucositis rate by more than half during radiotherapy,” the investigators commented. “It also alleviated oral pain and swallowing difficulties and reduced oral Staphylococcus aureus colonization rates.”
Study Details
A total of 176 patients with nasopharyngeal carcinoma undergoing definitive chemoradiotherapy were randomly assigned in a 1:1 ratio to receive standard oral and nasal care with or without bacterial decolonization therapy.
Based on the study’s standard oral care protocol, patients rinsed four times daily with 10 mL of Kangfuxin liquid (ethanol extract of the American cockroach) for 3 minutes, starting 3 days before and continuing throughout radiotherapy. Nasal irrigation with normal saline was performed twice daily. During the same period, those who were randomly assigned to receive bacterial decolonization therapy self-administered mupirocin ointment, applying it to the anterior nasal cavity once in the morning and again within 30 minutes before bedtime. This procedure was continued for 5 days, followed by a 1-week break, and repeated every 12 days.
The primary endpoint was the incidence of severe (grade ≥ 3) acute radiation-induced oral mucositis; assessments were performed by blinded independent evaluators. Secondary endpoints included quality of life, evaluated using the Quality-of-Life Questionnaire–Head and Neck 43 (QLQ-H&N43), and the colonization levels of S aureus in the nasal and oral mucosa.
Key Findings
Severe acute radiation-induced oral mucositis was reported in 22.7% and 47.7% of patients who did and did not receive bacterial decolonization therapy, respectively (relative risk = 0.48, 95% confidence interval [CI] = 0.31–0.74; P < .001). The effect of bacterial decolonization on severe acute radiation-induced oral mucositis risk reduction was confirmed by multivariable logistic analysis (odds ratio = 0.27, 95% CI = 0.13–0.54; P < .001).
Based on the QLQ-H&N43 assessment, during radiotherapy, standard care with vs without bacterial decolonization therapy significantly reduced the severity of oral pain (median score, 25.0 vs 50.0; P < .001) and swallowing difficulties (8.3 vs 33.3; P < .001). By the end of radiotherapy, the addition of bacterial decolonization therapy was found to result in lower colonization rates of S aureus (nasal: 9.4% vs 22.9%; oral: 5.9% vs 20.5%).
“By targeting S aureus colonization, this approach offers a cost-effective strategy for acute radiation-induced oral mucositis management,” the investigators concluded. “While further multicenter studies are required to validate these findings and explore synergistic effects with probiotics, this trial’s results highlight the potential of microbial management in reducing radiation [therapy]–related complications.”
Tianzhu Lu, MD, PhD, and Jingao Li, MD, of Jiangxi Cancer Hospital, the Second Affiliated Hospital of Nanchang Medical College, Nanchang, China, are the corresponding authors of the JAMA Oncology article.
Disclosure: The study was funded by the Science and Technology Research Project of Education Department of Jiangxi Province, Open Fund for Scientific Research of NHC Key Laboratory of Personalized Diagnosis and Treatment of Nasopharyngeal Carcinoma, National Natural Science Foundation of China, Jiangxi Province Key R&D Program, and “Five-level Progressive” talent cultivation project of Jiangxi Cancer Hospital & Institute. The study authors reported no conflicts of interest.
