NCT00168116已完成2 期
To Evaluate the Effects of Transfer of Submandibular Salivary Gland to the Submental Region (Outside the Radiation Field) on Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histological diagnosis of squamous cell carcinoma
- •Patients with unilateral or no neck involvement of the nasopharynx
- •The submandibular transfer will be done on the uninvolved side of the neck.
- •Karnofsky score greater than or equal to 70
- •Expected survival greater than one year
- •A signed informed consent
排除标准
- •Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.
结局指标
主要结局
Quality of life
次要结局
- Complications
- Incidence of oral candidiasis
- Overall survival
- Disease free survival
- Pattern of recurrence
- Treatment interruptions
- Incidence of percutaneous endoscopic gastronomy (PEG)
研究者
研究点 (1)
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