Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Summary

The purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (RT) for patients with nasopharyngeal carcinoma, can prevent high-grade radiation-induced oral mucositis (RIOM) and improve quality of life. This study is being conducted because a randomized clinical trials form Yana Kost et al. have found bacterial decolonization in the nose prior to initiation of RT was effective for prevention of acute radiation dermatitis. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and mouth, and participants will also complete a quality of life questionnaire before and after RT.

Timeline

Start

2023-07-01

Primary completion

2024-04-30

Completion

2024-12-31

Outcome

Met primary endpoint

paper In the BD group, severe AROM occurred in 20 of 88 patients (22.7%) compared with 42 (47.7%) in the SoC group (relative risk, 0.48; PMID 40773220 ↗

paper P < .001 PMID 40773220 ↗

paper BD with mupirocin nasal ointment effectively reduced severe AROM PMID 40773220 ↗

Publications

• Background Kost Y, Deutsch A, Mieczkowska K, Nazarian R, Muskat A, Hosgood HD, Lin J, Daily JP, Ohri N, Kabarriti R, Shinoda K, McLellan BN. Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):940-945. doi: 10.1001/jamaoncol.2023.0444.
• Liao Z, Xiong X, Zhao L, Zhang Z, Guan C, Zhang L, Zhong F, Rao J, Wang X, Xiao Y, Gong X, Huang SH, Li J, Lu T. Bacterial Decolonization With Mupirocin Ointment for Acute Radiation Oral Mucositis Prevention: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 1;11(10):1141-1149. doi: 10.1001/jamaoncol.2025.2361.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mupirocin	Small molecule	—	Intranasal

Indications