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临床试验/NCT02564887
NCT02564887
终止
不适用

Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy

Jonas Johnson1 个研究点 分布在 1 个国家目标入组 26 人2016年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Dysphagia
发起方
Jonas Johnson
入组人数
26
试验地点
1
主要终点
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
状态
终止
最后更新
6年前

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.

注册库
clinicaltrials.gov
开始日期
2016年1月
结束日期
2019年9月6日
最后更新
6年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

发起方
Jonas Johnson
责任方
Sponsor Investigator
主要研究者

Jonas Johnson

Professor and Chairman

University of Pittsburgh

入排标准

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)

研究点 (1)

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