The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
21 de julio de 2026 actualizado por: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of spirulina supplementation in patients with radiation-induced oral mucositis (RIOM) receiving radiotherapy for head and neck cancer.
Participants will be randomly assigned to receive either spirulina tablets or placebo in addition to standard oral care during radiotherapy.
The primary objective is to determine whether spirulina reduces the severity of oral mucositis.
Secondary outcomes include the incidence and duration of severe oral mucositis, oral pain, nutritional status, quality of life, treatment interruption, and adverse events.
The findings of this study may provide evidence for an effective and safe adjunctive intervention to improve the management of radiation-induced oral mucositis and enhance the quality of life of patients undergoing radiotherapy.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial evaluating spirulina as an adjunctive intervention for radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancer.
Radiation-induced oral mucositis is a common and clinically significant adverse effect of radiotherapy. It may cause oral pain, difficulty eating and swallowing, nutritional deterioration, reduced quality of life, and interruption of anticancer treatment. Current management is mainly supportive, and additional safe and effective interventions are needed.
Eligible participants will be randomized to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy. The study will compare the effects of spirulina and placebo on the severity, incidence, and duration of oral mucositis. Oral pain, nutritional status, quality of life, treatment compliance, radiotherapy interruption, and adverse events will also be evaluated.
The purpose of this trial is to determine whether spirulina supplementation can reduce the burden of radiation-induced oral mucositis and improve supportive care for patients undergoing radiotherapy. The safety of spirulina will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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.
Estudio Contacto
- Nombre: Haijiao Zhao, Master's Student
- Número de teléfono: 13858107163
- Correo electrónico: zhaohaijiao@zju.edu.cn
Ubicaciones de estudio
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Zhejiang
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Yiwu, Zhejiang, Porcelana, 322000
- Reclutamiento
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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Contacto:
- haijiao zhao
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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:
- Adults aged 18 years or older.
- Patients with radiation-induced oral mucositis (RIOM), recurrent aphthous stomatitis (RAS), or other clinically diagnosed oral ulcers, confirmed by clinical examination.
- Presence of at least one clinically active oral ulcer at the time of enrollment.
- Able to understand the study procedures and provide written informed consent.
- Willing and able to comply with all study procedures, follow-up visits, and assessments.
Exclusion Criteria:
Previous radiotherapy to the head and neck region.
- Known allergy or hypersensitivity to spirulina or its components.
- Severe hepatic, renal, cardiovascular, or other uncontrolled systemic diseases.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial during the study period.
- Any condition that, in the investigator's opinion, 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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Spirulina Group
Participants will receive spirulina tablets (3 g/day, 6 tablets daily) in addition to standard oral care.
The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy.
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Spirulina tablets will be administered at a dose of 3 g/day (6 tablets daily) from the first day of radiotherapy until completion of radiotherapy.
Otros nombres:
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Comparador de placebos: Placebo Group
Participants will receive matching placebo tablets (6 tablets daily) in addition to standard oral care.
The intervention will start on the first day of radiotherapy and continue until completion of radiotherapy.
|
Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
Otros nombres:
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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 and Clinical Characteristics of Oral Mucosal Ulcers
Periodo de tiempo: From Day 0 (before intervention) through Day 14, assessed daily.
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The incidence and clinical characteristics of oral mucosal ulcers were assessed by standardized oral examinations.
The number, location, maximum diameter, estimated ulcer area, erythema, pseudomembrane or exudate, and clinical severity of ulcers were recorded throughout the study.
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From Day 0 (before intervention) through Day 14, assessed daily.
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Oral Pain Intensity (Visual Analog Scale, VAS)
Periodo de tiempo: Day 0 (before intervention), Day 7, and Day 14.
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Oral pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain severity.
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Day 0 (before intervention), Day 7, and Day 14.
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Oral Microbiota Composition
Periodo de tiempo: Day 0 (before intervention), Day 7, and Day 14.
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Oral microbiota samples were collected for metagenomic sequencing to evaluate changes in microbial composition, microbial diversity, and relative abundance following the intervention.
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Day 0 (before intervention), Day 7, and Day 14.
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Salivary Biomarkers
Periodo de tiempo: Day 0 (before intervention), Day 7, and Day 14.
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Unstimulated saliva samples were collected to measure inflammatory and oxidative stress biomarkers, including IL-6, TNF-α, MDA, and SOD, to evaluate the biological effects of the intervention.
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Day 0 (before intervention), Day 7, and Day 14.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Xu Huang, PhD, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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 (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
1 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
23 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY-2026-085
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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