- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07567742
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
30 de abril de 2026 actualizado por: Jun Ma, MD, Sun Yat-sen University
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial
This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
130
Fase
- Fase 2
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.
Estudio Contacto
- Nombre: Jun Ma
- Número de teléfono: +86-20-87343469
- Correo electrónico: yangkb@sysucc.org.cn
Copia de seguridad de contactos de estudio
- Nombre: Yu-Pei Chen, MD
- Número de teléfono: +86-020-87343581
Ubicaciones de estudio
-
-
Guangdong
-
Guangzhou, Guangdong, Porcelana
- Sun Yat-sen University Cancer Center
-
Contacto:
- Jun Ma
- Número de teléfono: +862087343469
- Correo electrónico: majun2@mail.sysu.edu.cn
-
Investigador principal:
- Jun Ma
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18-70 years.
- Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).
- Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.
- Scheduled to receive radical intensity-modulated radiotherapy (IMRT).
- No prior history of anti-cancer treatment.
- ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin > 90 g/L; absolute neutrophil count > 1.5×10⁹/L; platelet count > 100×10⁹/L. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL/min.
- For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.
- Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.
Exclusion Criteria:
- Known intolerance or hypersensitivity to taurine or its excipients.
- Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- Prior history of malignant tumor.
- Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)
- History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.
- Unwilling to stop smoking, drinking alcohol, or chewing betel nut.
- Presence of severe active comorbidities.
- Severe dysfunction of heart, brain, lung, or other vital organs.
- Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.
- Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.
- Any other condition deemed inappropriate by the investigator.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Taurine
Oral taurine 1 g twice daily, starting 3 days before radiotherapy until 1 week after completion of radiotherapy, plus standard of care for RIOM.
|
Oral taurine 1 g twice daily, administered from 3 days before the start of radiotherapy until 1 week after the completion of radiotherapy.
|
|
Sin intervención: Control
Patients in the control arm will receive the standard of care for RIOM.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Severe Radiation-Induced Oral Mucositis
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
The incidence of Grade ≥3 radiation-induced oral mucositis (RIOM) in the experimental and control groups, as assessed using the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Onset Time of Severe Radiation-Induced Oral Mucositis
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
The interval from the start of radiotherapy to the first occurrence of severe radiation-induced oral mucositis (RIOM).
Severe RIOM is defined as Grade ≥3 according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
|
Duration of Severe Radiation-Induced Oral Mucositis
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
|
The interval from the first occurrence of severe acute radiation-induced oral mucositis (RIOM) to its resolution to Grade ≤2, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy.
|
|
Recovery Rate of Severe Radiation-Induced Oral Mucositis
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
The proportion of patients whose severe acute radiation-induced oral mucositis (RIOM) resolves to Grade ≤2 during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
Severe RIOM is defined as Grade ≥3 on the RTOG acute RIOM grading scale.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
|
Incidence of Radiation-Induced Oral Mucositis
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
The proportion of patients who develop any-grade acute radiation-induced oral mucositis (RIOM) (Grade ≥1) during the overall observation period, as assessed according to the Radiation Therapy Oncology Group (RTOG) acute RIOM grading scale.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
|
Incidence of Radiotherapy Interruption
Periodo de tiempo: From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
|
The proportion of patients who experience a radiotherapy interruption of 5 or more consecutive days during the radiotherapy period due to acute radiation-induced oral mucositis (RIOM) or other related adverse events.
|
From the start of radiotherapy through completion of radiotherapy, an average of 7 weeks.
|
|
Quality of life (QoL)
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
Quality of life related to head and neck symptoms will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Module (EORTC QLQ-H&N35), version 1.0.
This questionnaire comprises 35 items, including seven multi-item scales and 11 single-item measures.
All scales and items will be scored according to the official EORTC Scoring Manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater symptom burden and poorer quality of life.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
|
Numeric Rating Scale for Pain
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
Oral mucositis-related pain was assessed in all participants using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate worse pain.
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
|
Safety as Assessed by CTCAE
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
Adverse events were monitored and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
|
From the start of radiotherapy to 4 weeks after completion of radiotherapy
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jun Ma, Sun Yat-sen University
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 (Estimado)
6 de mayo de 2026
Finalización primaria (Estimado)
30 de marzo de 2027
Finalización del estudio (Estimado)
30 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Enfermedades Otorrinolaringológicas
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Enfermedades Nasofaríngeas
- Enfermedades faríngeas
- Neoplasias Nasofaríngeas
- Condiciones Patológicas, Signos y Síntomas
- El carcinoma nasofaríngeo
- Úlcera
- Estomatitis
- Compuestos de azufre
- Químicos orgánicos
- Hidrocarburos, acíclico
- Hidrocarburos
- Alcanos
- Ácidos alcanosulfónicos
- Ácidos sulfónicos
- Ácidos de azufre
- Taurina
Otros números de identificación del estudio
- 2026-FXY-049-FLK
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .