Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
研究概览
简要总结
Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.
排除标准
- •unable to adhere to assigned therapy program due to cognitive deficits
- •surgical treatment for head and neck cancer
- •unable to give informed consent
结局指标
主要结局
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
时间窗: 8 weeks
Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)
次要结局
- Swallowing Impairment-Self Report(8 week)
- Airway Protection During Swallowing(8 week)
- Swallowing Impairment(8 week)
- Change Over Time of Pharyngeal Residue After Swallowing(8 week)
- Swallowing Impairment-Objective(8 week)
研究者
Jonas Johnson
Professor and Chairman
University of Pittsburgh