The Effect of Prophylactic Swallowing Exercises on Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
研究概览
简要总结
The purpose of this study is to find out if doing prophylactic or preventative swallowing exercises from the start of cancer treatment can improve the ability to swallow when the treatment is completed and beyond.
详细描述
Study Type: Prospective Randomized Clinical Trial
Introduction:
Organ sparing treatment for advanced head and neck cancer can affect the swallowing mechanism via fibrosis of the structures responsible for effective and efficient bolus movement from the oral cavity and through the pharynx into the esophagus. This fibrosis may result in significant impairment of bolus transport. Range of motion exercises for the swallowing structures may decrease the fibrotic effects of the radiation treatment and improve swallowing outcomes after treatment.
Intervention:
Patients who have been diagnosed with head and neck cancer and who will be receiving radiation therapy either with or without chemotherapy as cancer treatment will be randomized to one of two swallowing treatment protocols. The first protocol will include the initiation of intensive swallowing exercises to begin at the start of the cancer treatment. The second treatment protocol will include the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient. Patients will not be given a choice of swallowing protocol. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis. The same investigator will provide all the swallowing treatment assuring that all patients get the same treatment approach.
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
- Single (Outcomes Assessor)
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
- •Patient diagnosed with head and neck cancer who will be receiving radiation therapy either alone of with chemotherapy as their treatment modality.
排除标准
- •Patients with a history of neurologic disease
- •Patients with previous head and neck cancer or surgical or radiation treatment to the head and neck region
- •Patients taking medication that might effect their swallowing function
- •Patients with gastroenterologic dysfunction
- •Patients who have previously undergone swallowing therapy
- •Patients with cognitive impairments that limit their ability to follow and comply with multi-step commands
研究组 & 干预措施
Swallowing Exercise Group
Swallowing Exercise Group: This arm will undergo the protocol that involves intensive swallowing exercises to begin at the start of the cancer treatment. Those patients randomized to the intensive therapy protocol will be required to participate in weekly swallowing therapy sessions either in person or over the phone and perform the learned swallowing exercises three times a day. In addition, these patients will document their swallowing practice on a daily basis.
干预措施: Swallowing Exercise Group (Behavioral)
Control
Control Arm: This arm will receive the standard of care which provides swallowing evaluation and treatment once symptoms of swallowing dysfunction are experienced by the patient.
结局指标
主要结局
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at 24 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at 3 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Performance Status Scale for Head and Neck Cancer Patients and Functional Oral Intake Scale (PSS-H&N).
时间窗: This will be completed at 12 months post treatment. Participants will be followed for up to 24 months after treatment.
This is a quick, clinician rated instrument consisting of three subscales: normalcy of diet, public eating and intelligibility of speech. This scale has been proven reliable across raters and sensitive to functional differences across a broad spectrum of head and neck cancer patients. The Performance Status Scale for Head and Neck Cancer Patients (PSS-H\&N) questionnaire will be completed at the start of the cancer treatment, at the completion of the treatment and at 3, 6, 12 and 24 months after treatment.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at the start of the cancer treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at the completion of treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at 3 post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
Functional Oral Intake Scale (FOIS)
时间窗: This will be completed at 6 months post treatment. Participants will be followed for up to 24 months after treatment.
A seven point scale of diet tolerance.
次要结局
未报告次要终点