Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
Effects of Early vs Late Onset of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer
RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.
PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.
研究概览
地位
条件
- 头颈癌
- I期喉癌
- II期喉癌
- Stage I Hypopharyngeal Cancer
- Stage I Oropharyngeal Cancer
- Stage II Hypopharyngeal Cancer
- Stage II Oropharyngeal Cancer
- Stage III Hypopharyngeal Cancer
- Stage III Laryngeal Cancer
- Stage III Oropharyngeal Cancer
- Stage IV Hypopharyngeal Cancer
- Stage IV Laryngeal Cancer
- Stage IV Oropharyngeal Cancer
详细说明
PRIMARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.
SECONDARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.
TERTIARY OBJECTIVE:
I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion
- Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
- Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
- Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
- Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
- Participants must be willing to participate in the swallowing exercise program
Exclusion
- Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
- Previous radiation treatment for head/neck cancer
- Swallowing problem of etiology other than current lesion
- Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm I (Early exercise group)
Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.
|
辅助研究
其他名称:
辅助研究
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT.
The late exercise group will start study exercises one month after the completion of XRT.
Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
|
实验性的:Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
|
辅助研究
其他名称:
辅助研究
The early exercise group will start study exercises approximately two weeks prior to the onset of XRT.
The late exercise group will start study exercises one month after the completion of XRT.
Participants will undergo an initial/pre-radiation and 1-, 3-, 6-, and 12 month post-radiation swallowing assessments.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
大体时间:Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
|
Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Penetration Aspiration Scale (PAS) as assessed via FEES
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Diet level (Dysphagia Outcome and Severity Scale (DOSS)) as assessed via FEES
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Feeding tube duration (days)
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Eating Assessment Tool (EAT) quality of life score
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Lingual strength as assessed by lingual manometry
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Percent weight loss
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Percent weight recovery
大体时间:Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
合作者和调查者
调查人员
- 首席研究员:Susan Butler、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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