Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measureable acute increase in xerostomia
研究概览
简要总结
The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.
详细描述
The parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. However, patients receiving whole brain radiation sometimes complain of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. In this study, investigators will use the validated University of Michigan Xerostomia Questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 Gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer).
- •Has not had prior radiation that would have exposed the parotids to a significant (estimated >10 Gy mean parotid dose) level of radiation within the past one year. Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated <1 Gy) radiation.
- •Greater than or equal to 18 years of age (no upper age limit).
- •Informed consent obtained.
排除标准
- •Patients receiving whole brain radiation without the use of a CT-based planning simulation.
- •Patients who are on medications known to cause dry mouth, such as anticholinergics.
- •Physically unable to communicate by paper or phone to complete the study survey.
- •Prisoners.
结局指标
主要结局
Measureable acute increase in xerostomia
时间窗: baseline to 1 month post-treatment
次要结局
- Association of degree of change in xerostomia score and the radiation dose received by the parotid glands(baseline to 1 month post-RT)
- Effect of whole brain radiation on the time course of xerostomia(baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT).)