Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment

Conditions
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Nasopharyngeal Carcinoma, Radiation-induced Oral Mucositis, Bacterial Colonization, Quality of Life

Intervention / Treatment
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* Drug: Mupirocin Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed nasopharyngeal carcinoma No evidence of distant metastasis (M0) ECOG (Eastern Cooperative OncologyGroup) scale 0-1 18-70 years old Exclusion Criteria: Previous or existing mental or cognitive impairment; Patients with other malignant tumors at the same time; Have received bacterial decolonization therapy; Oral mucositis or ulcers existed before radiotherapy. Prior RT to the region of interest

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>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. | Drug: Mupirocin Ointment<br>* Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares<br>|
| No Intervention: Control<br>Patients in the control arm will be treated according to standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |