Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy (CRT) for Cancers of the Head and Neck (HNCA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feeding-tube-free food intake (days)
研究概览
简要总结
This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).
详细描述
Thirty (30) persons with newly-diagnosed HNCA who will be treated with RT/CRT will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function. The training program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks, coincident with RT/CRT. Patients randomized to the Active EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Those randomized to the Sham EMST group will use an EMST150 device that has been modified to eliminate resistance to airflow.
All subjects will be evaluated prior to initiation of cancer treatment (baseline assessment), 4 weeks into cancer treatment and again at the completion of cancer treatment (8 weeks after initiation of treatment). Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, and administration of swallow-related quality of life (QOL) questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will not know whether the device that they are given has a functioning valve spring or whether the valve spring has been removed.
Researchers assessing the outcomes will not know the arm to which the subject was randomized.
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
- •New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;
- •Planned treatment with primary radiotherapy with or without chemotherapy;
- •Age 18 or older and able to provide consent;
- •Ability to use the EMST150 device (hold in mouth and maintain lip seal)
排除标准
- •Primary surgery to the head and neck (neck dissection is permitted);
- •Unknown primary tumor;
- •Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.
- •Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)
- •Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))
- •Prior history of head and neck radiotherapy
研究组 & 干预措施
Active EMST + Standard Care
Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.
干预措施: EMST (Other)
Sham EMST + Standard Care
Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.
干预措施: EMST (Other)
结局指标
主要结局
Feeding-tube-free food intake (days)
时间窗: 8 weeks
the number of days from the beginning of the study until change in feeding status from 100% oral intake to combined oral intake and tube intake and/or 100% tube feeding will be calculated
次要结局
- Presence of pharyngeal residue (dichotomous)(8 weeks)
- Extent of hyoid movement (mm)(8 weeks)
- Upper esophageal sphincter (UES) opening width (mm)(8 weeks)
- Penetration-Aspiration Scale rating (number)(8 weeks)
- Timing of Aspiration (category)(8 weeks)
研究者
Barbara Pauloski
Associate Professor
University of Wisconsin, Milwaukee