Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR)
18 de septiembre de 2020 actualizado por: Esther Marco Navarro, Parc de Salut Mar
Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
Head and neck cancer has a negative impact in swallowing function and quality of life.
Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions.
This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life.
The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.
Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.
Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Barcelona, España, 08024
- Hospital de l'Esperança
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with advanced head and neck cancer receiving radiotherapy
Exclusion Criteria:
- Candidates to surgical treatment
- Previous head and neck cancer
- Dysphagia due to causes other than cancer
- Previous head or neck radiation therapy.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Early rehabilitation
Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
|
Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day. All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months. |
|
Comparador activo: Later rehabilitation
Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
|
Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in dysphagia severity at three months post radiotherapy
Periodo de tiempo: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
|
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
|
2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
|
|
Change in quality of life at three months post radiotherapy
Periodo de tiempo: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
Head & Neck Cancer 35 (HN35)
|
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in dysphagia security signs at three months post radiotherapy
Periodo de tiempo: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test
|
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
|
Change in lingual Force at three months post radiotherapy
Periodo de tiempo: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
|
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Carroll WR, Locher JL, Canon CL, Bohannon IA, McColloch NL, Magnuson JS. Pretreatment swallowing exercises improve swallow function after chemoradiation. Laryngoscope. 2008 Jan;118(1):39-43. doi: 10.1097/MLG.0b013e31815659b0.
- Hutcheson KA, Lewin JS, Barringer DA, Lisec A, Gunn GB, Moore MW, Holsinger FC. Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2012 Dec 1;118(23):5793-9. doi: 10.1002/cncr.27631. Epub 2012 May 17.
- Kulbersh BD, Rosenthal EL, McGrew BM, Duncan RD, McColloch NL, Carroll WR, Magnuson JS. Pretreatment, preoperative swallowing exercises may improve dysphagia quality of life. Laryngoscope. 2006 Jun;116(6):883-6. doi: 10.1097/01.mlg.0000217278.96901.fc.
- Kotz T, Federman AD, Kao J, Milman L, Packer S, Lopez-Prieto C, Forsythe K, Genden EM. Prophylactic swallowing exercises in patients with head and neck cancer undergoing chemoradiation: a randomized trial. Arch Otolaryngol Head Neck Surg. 2012 Apr;138(4):376-82. doi: 10.1001/archoto.2012.187.
- Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective study of rehabilitation therapy in the treatment of radiation-induced dysphagia and trismus. Strahlenther Onkol. 2011 Jan;187(1):39-44. doi: 10.1007/s00066-010-2151-0. Epub 2010 Dec 10.
- Roe JW, Ashforth KM. Prophylactic swallowing exercises for patients receiving radiotherapy for head and neck cancer. Curr Opin Otolaryngol Head Neck Surg. 2011 Jun;19(3):144-9. doi: 10.1097/MOO.0b013e3283457616.
- Wall LR, Ward EC, Cartmill B, Hill AJ. Physiological changes to the swallowing mechanism following (chemo)radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2013 Dec;28(4):481-493. doi: 10.1007/s00455-013-9491-8.
- Stenson KM, MacCracken E, List M, Haraf DJ, Brockstein B, Weichselbaum R, Vokes EE. Swallowing function in patients with head and neck cancer prior to treatment. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):371-7. doi: 10.1001/archotol.126.3.371.
- Quer M, Leon X, Orus C, Recher K, Gras JR. [Analysis of 2,500 squamous cell carcinoma of the head and neck]. Acta Otorrinolaringol Esp. 2001 Apr;52(3):201-5. doi: 10.1016/s0001-6519(01)78198-8. Spanish.
- Lazarus CL. Effects of chemoradiotherapy on voice and swallowing. Curr Opin Otolaryngol Head Neck Surg. 2009 Jun;17(3):172-8. doi: 10.1097/MOO.0b013e32832af12f.
- Dirix P, Abbeel S, Vanstraelen B, Hermans R, Nuyts S. Dysphagia after chemoradiotherapy for head-and-neck squamous cell carcinoma: dose-effect relationships for the swallowing structures. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):385-92. doi: 10.1016/j.ijrobp.2008.11.041. Epub 2009 Jun 24.
- Murphy BA, Gilbert J. Dysphagia in head and neck cancer patients treated with radiation: assessment, sequelae, and rehabilitation. Semin Radiat Oncol. 2009 Jan;19(1):35-42. doi: 10.1016/j.semradonc.2008.09.007.
- Platteaux N, Dirix P, Dejaeger E, Nuyts S. Dysphagia in head and neck cancer patients treated with chemoradiotherapy. Dysphagia. 2010 Jun;25(2):139-52. doi: 10.1007/s00455-009-9247-7. Epub 2009 Aug 27.
- Lin PH, Hsiao TY, Chang YC, Ting LL, Chen WS, Chen SC, Wang TG. Effects of functional electrical stimulation on dysphagia caused by radiation therapy in patients with nasopharyngeal carcinoma. Support Care Cancer. 2011 Jan;19(1):91-9. doi: 10.1007/s00520-009-0792-2. Epub 2009 Nov 29.
- Tedla M, Valach M, Carrau RL, Varga I, Profant M, Mraz P, Weismann P. Impact of radiotherapy on laryngeal intrinsic muscles. Eur Arch Otorhinolaryngol. 2012 Mar;269(3):953-8. doi: 10.1007/s00405-011-1686-8. Epub 2011 Jul 8.
- Russi EG, Corvo R, Merlotti A, Alterio D, Franco P, Pergolizzi S, De Sanctis V, Ruo Redda MG, Ricardi U, Paiar F, Bonomo P, Merlano MC, Zurlo V, Chiesa F, Sanguineti G, Bernier J. Swallowing dysfunction in head and neck cancer patients treated by radiotherapy: review and recommendations of the supportive task group of the Italian Association of Radiation Oncology. Cancer Treat Rev. 2012 Dec;38(8):1033-49. doi: 10.1016/j.ctrv.2012.04.002. Epub 2012 Apr 27.
- Citak E, Tulek Z. Longitudinal quality of life in Turkish patients with head and neck cancer undergoing radiotherapy. Support Care Cancer. 2013 Aug;21(8):2171-83. doi: 10.1007/s00520-013-1774-y. Epub 2013 Mar 9.
- Long YB, Wu XP. A randomized controlled trail of combination therapy of neuromuscular electrical stimulation and balloon dilatation in the treatment of radiation-induced dysphagia in nasopharyngeal carcinoma patients. Disabil Rehabil. 2013 Mar;35(6):450-4. doi: 10.3109/09638288.2012.697250. Epub 2012 Jul 4.
- Rathod S, Gupta T, Ghosh-Laskar S, Murthy V, Budrukkar A, Agarwal J. Quality-of-life (QOL) outcomes in patients with head and neck squamous cell carcinoma (HNSCC) treated with intensity-modulated radiation therapy (IMRT) compared to three-dimensional conformal radiotherapy (3D-CRT): evidence from a prospective randomized study. Oral Oncol. 2013 Jun;49(6):634-42. doi: 10.1016/j.oraloncology.2013.02.013. Epub 2013 Apr 4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2016
Finalización primaria (Actual)
1 de abril de 2020
Finalización del estudio (Actual)
1 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
15 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2016
Publicado por primera vez (Estimar)
14 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014/5707/l
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Early rehabilitation
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalDesconocido
-
Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.TerminadoEnfermedad de la arteria coronariaEstados Unidos
-
University of Wisconsin, MadisonPenn State UniversityTerminado
-
University of Wisconsin, MadisonPenn State UniversityTerminadoObesidad | Pobreza
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminado
-
University of KonstanzWorld BankDesconocidoTrastorno de estrés postraumático | Agresión apetitivaCongo
-
University of RochesterReclutamiento
-
Hôpital le VinatierHospices Civils de Lyon; University Hospital, Strasbourg, France; Versailles Hospital y otros colaboradoresTerminadoDesorden del espectro autistaFrancia
-
Vanderbilt University Medical CenterTerminadoEstrés | Desorden del espectro autista | PadresEstados Unidos
-
Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...SuspendidoCrianza de los hijos | Problema de comportamiento infantil | Crianza de los hijosEstados Unidos