Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- High-grade radiation-induced oral mucositis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed nasopharyngeal carcinoma
- •No evidence of distant metastasis (M0)
- •ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- •18-70 years old
排除标准
- •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
研究组 & 干预措施
Treatment Arm
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.
干预措施: Mupirocin Ointment (Drug)
结局指标
主要结局
High-grade radiation-induced oral mucositis
时间窗: 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)
Grade 3 or higher radiation-induced oral mucositis according to RTOG
次要结局
- High-grade radiation dermatitis(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(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))