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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 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 radiation-induced oral mucositis(RIOM) and improve quality of life. |
|
| Control | No Intervention | Patients in the control arm will be treated according to standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin Ointment | Drug | Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares |
| Measure | Description | Time Frame |
|---|---|---|
| High-grade radiation-induced oral mucositis | Grade 3 or higher radiation-induced oral mucositis according to RTOG | radiation-induced oral mucositis(graded by the RTOG) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| High-grade radiation dermatitis | Grade 3 or higher radiation-induced dermatitis according to RTOG | Radiation dermatitis (graded by the CTCAE) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) |
| Quality of Life according QLQ-H&N43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianzhu Lu, PhD | Contact | 8615270186250 | lutianzhu2008@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37140904 | 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. | |
| 40773220 | Derived |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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EORTC QLQ-H&N43 |
| Quality of Life (according QLQ-H&N43) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) |
| 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. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |