The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa

Официальное название

The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Spirulina Tablets
  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.
• Другое Placebo Tablets
  Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.

Первичные конечные точки

• Incidence and Clinical Characteristics of Oral Mucosal Ulcers [Срок оценки: From Day 0 (before intervention) through Day 14, assessed daily.]
• Oral Pain Intensity (Visual Analog Scale, VAS) [Срок оценки: Day 0 (before intervention), Day 7, and Day 14.]
• Oral Microbiota Composition [Срок оценки: Day 0 (before intervention), Day 7, and Day 14.]
• Salivary Biomarkers [Срок оценки: Day 0 (before intervention), Day 7, and Day 14.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu

Идентификаторы

NCT: NCT07723612 · KY-2026-085

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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