- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01766349
Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients
Effect of Concurrent Chemoradiation Therapy on Respiratory Muscle Performance, Lung Function and Functional Capacity in Patients With Primary Esophagus Cancer
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background and Purpose: Incidence rates of esophageal cancer vary internationally with the higher rate found in Eastern Asia. Preoperative concurrent chemoradiation therapy (CCRT) for resectable esophageal cancer has been shown to improve overall survival in meta-analyses. Preoperative pulmonary function and functional capacity are known predictive factors for the development of postoperative pulmonary complications in patient undergoing major cancer surgery. Little is known concerning the impacts of preoperative CCRT on pulmonary function and functional capacity in patients with esophageal cancer. The aim of this study is to examine changes of respiratory performance and functional exercise capacity during RT or CCRT, the relations between these changes, and the impacts of these changes on the postoperative outcomes in patients with esophageal cancer.
Method: Patients with newly diagnosed esophageal cancer without metastasis will be recruited from the Far Eastern Memorial Hospital. Demographic data will be obtained from the chart. Respiratory muscle strength will be measured by maximal inspiratory and expiratory pressure. Spirometric variables will be tested by force expiratory volume in one second and forced vital capacity. Dyspnea will be measured using modified Borg scale. Functional exercise capacity will be measured by six minute walk distance. Quality of life will be measured using EORTC QOL-C30 and QOL-OES18 instruments. All the measurements will be repeated weekly during the concurrent therapy period. Repeated measure ANOVA will be used for analyzing difference among various time points. Spearman correlation coefficient will be used to test relationship between multiple variables. For patients who are receiving esophagectomy after CCRT or RT, pulmonary complications and total length of hospital stay will be documented.
Clinical relevance: The results of this study will help to better understand the indications for chest physiotherapy (e.g., respiratory muscle weakness, reduced functional capacity, and their related sequels)
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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New Taipei City, Taiwán
- Far Eastern Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- primary esophagus cancer
- planning to receive radiation therapy
Exclusion Criteria:
- MMSE < 24
- A clinical diagnosis affecting respiratory muscle function and functional activity performance
- Unstable angina or acute myocardial infarction prior 1 month of assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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esophagus cancer patients
Respiratory muscle performance will be followed in patients with esophagus cancer during CCRT or RT treatments.
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Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes of respiratory muscle performance (MIP/MEP, PFT)from baseline
Periodo de tiempo: Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Maximum inspiratory pressure (MIP) Maximum expiratory pressure (MEP) PFT: FEV1, FVC, FEV1/FVC
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Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes of functional exercise capacity, dyspnea, and quality of life from baseline
Periodo de tiempo: Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Functional exercise capacity will be measured using six-minute walk test.
Modified Borg scale will be used to measure dyspnea.
EORTC QOL-C30 and QOL-OES18 instruments will be used to measure Quality of life.
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Baseline, during CCRT or RT treatment (Day 5, Day 10, Day 15, Day 20, Day 25), 2 weeks after the completion of the treatment, 1 day pre-operation, and 1 month after operation
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Prevalence of pulmonary complications
Periodo de tiempo: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Data will be retrieved from the chart.
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During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Total length of hospital stay
Periodo de tiempo: During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Data will be retrieved from the chart.
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During hospital stay after esophagectomy (average hospitalization after the operation ranges from 1 month to 3 months)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chen-Hsi Hsieh, MD., Ph.D., Department of Radiation Oncology, Far Eastern Memorial Hospital
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FEMH-IRB-100066-E
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