Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores
研究概览
简要总结
The purpose of this study is to learn whether nasal saline irrigation is beneficial to patients undergoing radiation therapy for oropharyngeal cancer.
详细描述
In this study, subjects are randomized to one of two study arms. They are either randomized to receive nasal saline irrigation treatment (treatment group) or not to receive any nasal irrigation treatment (control group). Subjects randomized to the treatment group will be provided with saline packets to mix with water. All study subjects will be asked to complete questionnaires during the study. If a subject completes all study related activities, their total length of participation in the study will last about 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All patients seen in the KUMC Ear, Nose and Throat clinic with oropharyngeal cancer that have undergone radiation therapy as the primary treatment
排除标准
- •Patients that are at high risk for infection secondary to nasal irrigation
- •Patients with autoimmune disease or immune deficiency
结局指标
主要结局
Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores
时间窗: Change from Baseline to Month 2
Outcome measured using Sino-Nasal Outcome Test (SNOT-20) summary scores. Scores will be collected at the baseline visit and again on the Month 2 visit. Outcome represented as a change in mean summary scores between the two visits. Scores can range from 0-5 with 0 being the best and 5 being the worst.
次要结局
未报告次要终点
研究者
Lisa Shnayder
Associate Professor
University of Kansas Medical Center