Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Jiangxi Provincial Cancer Hospital176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

176

Conditions

Nasopharyngeal Carcinoma Radiation-induced Oral Mucositis Bacterial Colonization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with newly histologically confirmed nasopharyngeal carcinoma 2. No evidence of distant metastasis (M0) 3. ECOG (Eastern Cooperative OncologyGroup) scale 0-1 4. 18-70 years old Exclusion Criteria: 1. Previous or existing mental or cognitive impairment; 2. Patients with other malignant tumors at the same time; 3. Have received bacterial decolonization therapy; 4. Oral mucositis or ulcers existed before radiotherapy. 5. Prior RT to the region of interest

Outcomes

Primary Outcomes

High-grade radiation-induced oral mucositis

Grade 3 or higher radiation-induced oral mucositis according to RTOG

Time frame: 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 Outcomes

High-grade radiation dermatitis

Grade 3 or higher radiation-induced dermatitis according to RTOG

Time frame: 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

Time frame: 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)