Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
9 de julio de 2026 actualizado por: Xingchen Peng, West China Hospital
Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Radiotherapy (RT) is a cornerstone treatment for patients with head and neck cancer and may be administered as definitive, adjuvant, or concurrent therapy with chemotherapy depending on disease stage and clinical indication.
Despite its therapeutic benefits, RT is frequently associated with a range of acute toxicities, among which radiation dermatitis is one of the most common and clinically relevant adverse effects.
Radiation-induced skin injury may present during or shortly after the course of radiotherapy and can significantly impact patient comfort, treatment adherence, and overall quality of life.
Severe cases may lead to treatment interruption or dose modification, potentially compromising oncologic outcomes.
The incidence of acute radiation dermatitis in patients with head and neck cancer has been reported to be high, with a substantial proportion of patients developing at least moderate-grade skin reactions during the course of radiotherapy.
However, current preventive and therapeutic strategies remain limited, and no universally accepted standard of care has been established.
Existing supportive measures are primarily empirical and have shown variable efficacy in reducing the severity or progression of skin toxicity.
Superoxide dismutase (SOD) is an endogenous antioxidant enzyme with the ability to catalyze the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress-induced cellular damage.
Given that oxidative stress is a key mechanism underlying radiation-induced skin injury, topical application of SOD-based formulations may provide a biologically plausible approach for mitigating radiation dermatitis.
Based on this rationale, the present clinical trial is designed to investigate the efficacy and safety of a topical SOD skin spray in preventing and reducing acute radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
140
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: Xingchen Peng
- Número de teléfono: +86 18980606753
- Correo electrónico: pxx2014@163.com
Copia de seguridad de contactos de estudio
- Nombre: Yu Min
- Número de teléfono: 13108175138
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- Sichuan University West China Hospital
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Contacto:
- Xingchen Peng
- Número de teléfono: +86 18980606753
- Correo electrónico: pxx2014@163.com
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Contacto:
- Yu Min
- Número de teléfono: 13108175138
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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:
- Histologically confirmed malignant tumors of the head and neck without distant metastasis.
- Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.
- Age 18-80 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Signed informed consent form.
- Adequate cognitive and reading abilities to complete the questionnaire.
Exclusion Criteria:
- Pre-existing skin disease or open wounds in the irradiation field.
- Have a history of head and neck radiotherapy.
- Autoimmune or connective tissue disorders affecting skin.
- Known allergy to any component of study formulations.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo excipient spray
A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.
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Patients are instructed to apply a placebo excipient spray without superoxide dismutase evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily, following the same schedule as the experimental group.
Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first.
Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
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Experimental: Superoxide dismutase containing skin spray
A topical skin spray containing superoxide dismutase
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Patients are instructed to apply a topical superoxide dismutase-containing spray evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily.
Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first.
Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of grade ≥ 2 ARD
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale.
The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis.
Grade 0 means no change over baseline.
Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating.
Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema.
Grade 3 means confluent, moist desquamation other than skin folds; pitting edema.
Grade 4 means ulceration, hemorrhage, necrosis.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to onset of grade ≥ 2 ARD between the two arms.
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Duration of grade ≥ 2 ARD between the two arms.
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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The first determination of grade 2 or higher radiation dermatitis to the first instance of grade 1 or 0 radiation dermatitis, without a subsequent instance of grade 2 or higher radiation dermatitis.
Patients without observed grade 2 or higher radiation dermatitis were assigned a duration of 0 days.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Maximum dermatitis grade
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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The maximum grade of RTOG skin toxicity between 0 and 4.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Grade ≥3 radiation dermatitis incidence
Periodo de tiempo: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale.
The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis.
Grade 0 means no change over baseline.
Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating.
Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema.
Grade 3 means confluent, moist desquamation other than skin folds; pitting edema.
Grade 4 means ulceration, hemorrhage, necrosis.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estado General de Salud y Dimensiones Fundamentales de la Calidad de Vida
Periodo de tiempo: El período total de evaluación es aproximadamente de 14 a 14.5 semanas.
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Este instrumento es una medida de resultados reportados por el paciente (PRO) de 30 ítems diseñada para evaluar aspectos fundamentales de la calidad de vida relacionada con la salud en pacientes con cáncer, incluyendo 5 escalas funcionales (física, de rol, cognitiva, emocional, social), 3 escalas de síntomas (fatiga, dolor, náuseas y vómitos), una escala de estado de salud global/calidad de vida y 6 medidas de síntomas de un solo ítem.
Las puntuaciones se transforman linealmente a un rango de 0-100.
Para las escalas funcionales y la escala de estado de salud global, puntuaciones más altas indican mejores niveles funcionales o calidad de vida; para las escalas/ítems de síntomas, puntuaciones más altas indican una mayor carga de síntomas.
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El período total de evaluación es aproximadamente de 14 a 14.5 semanas.
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Síntomas Específicos del Cáncer de Cabeza y Cuello
Periodo de tiempo: El período total de evaluación es de aproximadamente 14 a 14,5 semanas.
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El EORTC QLQ-H&N35 es un instrumento de resultados informados por el paciente (PRO) diseñado específicamente para evaluar los síntomas relacionados con la enfermedad y los efectos secundarios relacionados con el tratamiento en pacientes con cáncer de cabeza y cuello.
Consta de 35 ítems, organizados en siete subescalas de múltiples ítems (dolor, deglución, sentidos, habla, alimentación social, contacto social y sexualidad) y once medidas de un solo ítem (como problemas dentales, problemas para abrir la boca, saliva espesa, tos, etc.).
Todas las puntuaciones de las subescalas y de los ítems individuales se transforman linealmente a una escala de 0-100 mediante un algoritmo de puntuación estandarizado.
Interpretación de las puntuaciones: Para todas las subescalas e ítems individuales, las puntuaciones más altas representan síntomas más graves o una mayor carga de síntomas.
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El período total de evaluación es de aproximadamente 14 a 14,5 semanas.
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Radiotherapy interruption rate
Periodo de tiempo: Up to 8 weeks (from initiation to completion of radiotherapy)
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Radiotherapy interruption is defined as an unplanned prolongation of the radiotherapy schedule resulting in a delay of ≥5 days compared with the planned treatment schedule, excluding scheduled breaks.
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Up to 8 weeks (from initiation to completion of radiotherapy)
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Patient-reported skin symptoms from the Skindex-16
Periodo de tiempo: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the skin-related QoL of patients.
Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with acne.
The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.
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From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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Skin microbiome composition and diversity
Periodo de tiempo: Baseline and end of radiotherapy (approximately 8 weeks after radiotherapy initiation)
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Skin microbiome composition and diversity will be assessed as an exploratory endpoint using 16S rRNA gene sequencing.
Skin swab samples will be collected from the irradiated skin area at baseline (before radiotherapy initiation) and at completion of radiotherapy.
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Baseline and end of radiotherapy (approximately 8 weeks after radiotherapy initiation)
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Periodo de tiempo: From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.
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From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Xingchen Peng, study principal investigator
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)
15 de julio de 2026
Finalización primaria (Estimado)
30 de diciembre de 2026
Finalización del estudio (Estimado)
30 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026(819)
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
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