Eficacia y Seguridad de la Terapia de Oxígeno Hiperbárico en la Mejora de la Neuropatía Periférica Inducida por Nab-paclitaxel
Eficacia y Seguridad de la Terapia de Oxígeno Hiperbárico en la Mejora de la Neuropatía Periférica Inducida por Nab-paclitaxel: Un Ensayo Clínico Aleatorizado
The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kun Wang, PhD
- Número de teléfono: +8615989223200
- Correo electrónico: gzwangkun@126.com
Copia de seguridad de contactos de estudio
- Nombre: Yingcong Lin, Master of Medicine
- Número de teléfono: +8618666885689
- Correo electrónico: 18666885689@163.com
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510080
- Reclutamiento
- Guangdong Provincial People's Hospital
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Contacto:
- Kun Wang
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Contacto:
- Wang Kun PhD, Doctor
- Número de teléfono: 15989223200
- Correo electrónico: gzwangkun@126.com
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Guangdong Provincial People's Hospital
-
Contacto:
- Yingcong Lin, master of medicine
- Número de teléfono: +86 18666885689
- Correo electrónico: 18666885689@163.com
-
Contacto:
- Kun Wang, PhD
- Número de teléfono: +8613922118086
- Correo electrónico: gzwangkun@126.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- aged ≥ 18 years and ≤ 75 years, female
- early-stage breast cancer or locally advanced breast cancer
- Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
- The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10.
- The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
Exclusion Criteria:
- Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
- Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
- Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
- Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
- Karnofsky Performance Status score < 80
- Patients with any other conditions that the investigator deems unsuitable for participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HBOT group
hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
|
Otro: Control group
Standard care |
Standard care |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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EORTC QLQ-CIPN20 subscales
Periodo de tiempo: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
|
Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NCI-CTCAE 5.0
Periodo de tiempo: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4 |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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EORTC QLQ-C30
Periodo de tiempo: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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BPI-SF
Periodo de tiempo: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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Nerve Conduction Velocity
Periodo de tiempo: baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
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Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kun Wang, Guangdong Provincial People's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- KY2026-046-02
Información sobre medicamentos y dispositivos, documentos del estudio
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