Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Xerostomia-related quality of life
研究概览
简要总结
Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Newly diagnosis AJCC 8th edition Stage III/IVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).
排除标准
- •Previous radiation to the head and neck
- •Previous treatment for head and neck cancer
- •Personal history of xerostomia
- •Hypersensitivity to onabotulinumtoxinA
- •Previous major salivary gland surgery
- •Previous exposure to radioactive iodine therapy
研究组 & 干预措施
Placebo
The treating physician will perform the injection of normal saline under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of normal saline will be infiltrated the major salivary glands at-risk.
干预措施: Placebo (Drug)
onabotulinumtoxinA
The treating physician will perform the injection of onabotulinumtoxinA under ultrasound guidance using a 30-gauge needle introduced into the salivary gland tissue. 30 units of onabotulinumtoxinA will be infiltrated the major salivary glands at-risk.
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Xerostomia-related quality of life
时间窗: Pretreatment, 6 and 12 months from treatment completion
University of Washington Quality of Life questionnaire (higher score is better)
次要结局
- Unstimulated salivary function using salivary gland scintigraphy(Pretreatment and 12 months from treatment completion)
研究者
Marco Mascarella
Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital