NCT00168181已完成3 期
A Phase III Randomized Trial Comparing Oral Pilocarpine (Salagen) Versus Submandibular Salivary Gland Transfer Protocol, For the Prevention of Radiation (XRT) Induced Xerostomia in Head and Neck Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- To compare the efficacy of prevention of XRT induced xerostomia using two different approaches: oral Pilocarpine versus submandibular salivary gland transfer protocol; To compare the rate and severity of XRT induced xerostomia using these two strategies
研究概览
简要总结
This is a study to see whether the drug Salagen or salivary gland transfer is better for the prevention of dryness of the mouth in patients with head and neck cancer receiving radiation treatment.
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
- 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
- •Previously untreated and confirmed histological diagnosis of squamous cell/adenoid cystic carcinoma of the oropharynx, hypopharynx, larynx, and patients with unknown primary tumor with metastases to the neck nodes and squamous cell carcinoma of the skin of head and neck region with ipsilateral neck nodes (more than one node) metastases.
- •Radiation volume to encompass > or equal to 80% of major salivary glands (parotids and the non-transferred submandibular salivary gland) and have > or equal to 50 Gys delivered to that volume via external beam.
- •Karnofsky performance score > or equal to 70
- •Minimum age 18 years
- •The patient must sign a study-specific informed consent prior to study entry
- •Expected survival > or equal to one year
排除标准
- •Carcinoma of nasopharynx, oral cavity, N3 disease, bilateral neck node involvement, pre-epiglottic space involvement, involvement of level 1 nodes on either side of the neck, and patients with post-operative recurrent disease.
- •Salivary gland malignancy
- •Salivary gland disease
- •Use of anti-cholinergic drugs and tricyclic drugs
- •Delay in XRT of more than 8 weeks following the curative surgery
- •Pregnant or lactating females are not eligible. Patients of childbearing potential should agree to use an effective method of contraception
- •Prior head and neck irradiation
- •Recurrent disease
- •Allergy to pilocarpine
- •Patients with uncontrolled asthma, acute iritis, or narrow angle glaucoma
结局指标
主要结局
To compare the efficacy of prevention of XRT induced xerostomia using two different approaches: oral Pilocarpine versus submandibular salivary gland transfer protocol; To compare the rate and severity of XRT induced xerostomia using these two strategies
次要结局
- To evaluate the incidence of oral candidiasis, percutaneous endoscopic gastrostomy (PEG), and hospitalization during XRT
研究者
研究点 (2)
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