- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01053546
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.
Descripción general del estudio
Estado
Condiciones
- Cáncer de cabeza y cuello
- Cáncer de laringe en estadio I
- Cáncer de laringe en estadio II
- 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
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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.
|
Estudio auxiliar
Otros nombres:
Estudio auxiliar
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.
|
Experimental: Arm II (Late exercise group)
Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.
|
Estudio auxiliar
Otros nombres:
Estudio auxiliar
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
M.D. Anderson Dysphagia Inventory (MDADI) swallowing quality of life score
Periodo de tiempo: Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
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Baseline and at 1, 3, 6, and 12 months following completion of radiotherapy
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Penetration Aspiration Scale (PAS) as assessed via FEES
Periodo de tiempo: 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
Periodo de tiempo: 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
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Feeding tube duration (days)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Percent weight loss
Periodo de tiempo: Baseline and at 1, 3, and 6 months following completion of radiotherapy
|
Baseline and at 1, 3, and 6 months following completion of radiotherapy
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Percent weight recovery
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Susan Butler, Wake Forest University Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Enfermedades faríngeas
- Enfermedades Estomatognáticas
- Enfermedades Otorrinolaringológicas
- Enfermedades de la laringe
- Neoplasias de Cabeza y Cuello
- Neoplasias orofaríngeas
- Neoplasias Laríngeas
- Neoplasias Hipofaríngeas
Otros números de identificación del estudio
- IRB00010437
- NCI-2009-01445 (Otro identificador: CTRP)
- CCCWFU 98109 (Otro identificador: Wake Forest University Health Sciences)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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