- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00503776
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia
Randomized Pilot Trial of Chemoradiation Plus or Minus Amifostine to Assess Potential Nutritional, Inflammatory and Physical Outcomes Related to Xerostomia, Mucositis and Dysphagia
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine in treating head and neck cancer.
PURPOSE: This randomized phase II trial is studying amifostine to see how well it works compared with standard care in reducing side effects in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
- To assess the relative incidence and severity of acute and chronic xerostomia in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the relative incidence and severity of mucositis and mucositis-related inflammation in stage III or IV head and neck cancer patients receiving chemoradiation with or without amifostine.
- To assess the effects of dysphagia, xerostomia, and mucositis-related inflammation on nutritional, physical, and functional status
OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy comprising carboplatin and paclitaxel weekly.
Patients are randomized to 1 of 2 treatment arms.
Arm I (standard of care): Patients are further divided into 1A or 1B.
- Arm IA: Standard of care plus standardized nutrition therapy (SNT)
- Arm IB: Standard of care plus standardized nutrition therapy plus low weight resistance training (LWRT).
Arm II (amifostine): Patients are further divided into 2A or 2B.
- Arm IIA: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy
- Arm IIB: Amifostine 500mg diluted in 2.9 ml injected 30-60 minutes prior to each radiation dose plus standardized nutrition therapy plus low weight resistance training
In all arms, patients undergo swallowing function, dietary, body composition, muscle, and physical and functional performance measurements at baseline and at 1, 3, and 6 months post-therapy. Quality of life, salivary production, fatigue, and symptoms (including swallowing/eating foods, appetite, weight loss/nutrition, pain, and speech/communication) are assessed at baseline and at 1, 3, and 6 months post-therapy. Anthropometric measurements are also performed at the above time points and at mid-therapy.
Blood samples and buccal rinses are collected at baseline and at 1, 3, and 6 months post-therapy for biomarker studies and for proteomic and genomic analysis by liquid chromatography and tandem mass spectrometry.
After completion of study treatment, patients are followed at 1, 3, and 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232-6838
- Vanderbilt-Ingram Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Age greater than 21
- Biopsy proven stage 3 or 4 squamous cell carcinoma of the larynx, pharynx, oral cavity or salivary glands
- No prior history of active cancer within three years other than non-melanoma skin cancer, early stage prostate or early stage cervical cancer
- controlled co-morbid disease
- ECOG PS of 0-3
- Plan for definitive or post-operative CCR within 4 weeks
- Written informed consent
- Working telephone
- May have received prior induction chemotherapy
- Agree to use only study supplied liquid nutrition supplements or dietary supplements, for per os or feeding tube intake
Exclusion Criteria
- Diagnosed HIV or AIDS
- History of ETOH or drug abuse within 3 months
- Pregnant or lactating
- On steroid medication or prescribed NSAIDs
- Consuming specialty nutrition supplements containing additional amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA)
- On orexigenic (appetite stimulant) medication.
- Uncontrolled comorbid disease defined as: a) severe cardiac disease Class III or greater; b) blood pressure > 160/95; c) uncontrolled pain
- Does not have working telephone.
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 |
---|---|
Comparador activo: Arm IA
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
|
Comparador activo: Arm IB
Patients undergo SNT and low weight resistance training (LWRT).
|
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Patients undergo low weight resistance training.
|
Experimental: Arm IIA
Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT).
Patients also undergo SNT as in arm IA.
|
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Given subcutaneously
Otros nombres:
|
Experimental: Arm IIB
Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT.
Patients also undergo SNT and LWRT as in arm IB.
|
Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
Patients undergo low weight resistance training.
Given subcutaneously
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Patients With Each Degree of Swallowing Dysfunction
Periodo de tiempo: 6 months after concurrent chemotherapy and radiation
|
Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment
|
6 months after concurrent chemotherapy and radiation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Stimulated and Unstimulated Salivary Production
Periodo de tiempo: 6 months after concurrent chemotherapy and radiation
|
Unstimulated and stimulated salivary production, measured in mL/minute.
Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods.
Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.
|
6 months after concurrent chemotherapy and radiation
|
Number of Patients With Oral Mucositis by Grade
Periodo de tiempo: 6 months after concurrent chemotherapy and radiation
|
Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).
|
6 months after concurrent chemotherapy and radiation
|
Changes in the Amount and Texture of Food Consumed
Periodo de tiempo: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
|
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.
|
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
|
Changes in the Frequency and Types of Dietary Intakes
Periodo de tiempo: at baseline, at 1 month, 3 months and 6 months post-chemoradiation
|
Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.
|
at baseline, at 1 month, 3 months and 6 months post-chemoradiation
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center
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
Palabras clave
- Carcinoma de células escamosas de labio y cavidad oral en estadio III
- Carcinoma verrugoso de la cavidad oral en estadio III
- Carcinoma de células escamosas de labio y cavidad oral en estadio IV
- Carcinoma verrugoso de la cavidad oral en estadio IV
- Carcinoma recurrente de células escamosas de labio y cavidad oral.
- carcinoma verrugoso recurrente de la cavidad oral
- Carcinoma de células escamosas de orofaringe en estadio III
- Carcinoma de células escamosas de la orofaringe en estadio IV
- carcinoma de células escamosas recurrente de la orofaringe
- Carcinoma de células escamosas de la nasofaringe en estadio III
- Carcinoma de células escamosas de la nasofaringe en estadio IV
- carcinoma de células escamosas recurrente de la nasofaringe
- Carcinoma epidermoide de hipofaringe en estadio III
- Carcinoma de células escamosas de hipofaringe en estadio IV
- carcinoma de células escamosas recurrente de hipofaringe
- Carcinoma de células escamosas de laringe en estadio III
- Carcinoma verrucoso de laringe en estadio III
- Carcinoma de células escamosas de laringe en estadio IV
- Carcinoma verrugoso de laringe en estadio IV
- carcinoma de células escamosas recurrente de laringe
- carcinoma verrugoso recurrente de laringe
- cáncer de glándulas salivales recurrente
- cáncer de glándulas salivales en estadio III
- cáncer de glándulas salivales en estadio IV
- toxicidad de la radiación
- mucositis
- carcinoma de células escamosas de las glándulas salivales
- disfagia
- xerostomía
- toxicidad del agente quimioterapéutico
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Gastroenteritis
- Enfermedades faríngeas
- Enfermedades Estomatognáticas
- Enfermedades Otorrinolaringológicas
- Enfermedades de la Boca
- Enfermedades esofágicas
- Enfermedades de las glándulas salivales
- Trastornos de la deglución
- Mucositis
- Xerostomía
- Efectos fisiológicos de las drogas
- Agentes Protectores
- Agentes de protección contra la radiación
- Amifostina
Otros números de identificación del estudio
- VICC HN 0554
- VU-VICC-HN-0554
- VU-VICC-IRB-051068
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 therapeutic dietary intervention
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Universitätsklinikum Hamburg-EppendorfGerman Research FoundationTerminado