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.
Обзор исследования
Статус
Условия
- Рак головы и шеи
- Рак гортани I стадии
- Рак гортани II стадии
- 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
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27157
- Wake Forest University Health Sciences
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Дополнительное исследование
Другие имена:
Дополнительное исследование
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.
|
|
Экспериментальный: Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
|
Дополнительное исследование
Другие имена:
Дополнительное исследование
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
Временное ограничение: 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
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Penetration Aspiration Scale (PAS) as assessed via FEES
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Eating Assessment Tool (EAT) quality of life score
Временное ограничение: Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
|
Lingual strength as assessed by lingual manometry
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Соавторы и исследователи
Следователи
- Главный следователь: Susan Butler, Wake Forest University Health Sciences
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Новообразования
- Новообразования по локализации
- Новообразования дыхательных путей
- Новообразования глотки
- Оториноларингологические новообразования
- Заболевания глотки
- Стоматогнатические заболевания
- Оториноларингологические заболевания
- Заболевания гортани
- Новообразования головы и шеи
- Новообразования ротоглотки
- Новообразования гортани
- Гипофарингеальные новообразования
Другие идентификационные номера исследования
- IRB00010437
- NCI-2009-01445 (Другой идентификатор: CTRP)
- CCCWFU 98109 (Другой идентификатор: Wake Forest University Health Sciences)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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