The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Haijiao Zhao, Master's Student
- 电话号码：13858107163
- 邮箱：zhaohaijiao@zju.edu.cn
学习地点
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Zhejiang
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Yiwu、Zhejiang、中国、322000
- 招聘中
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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接触：
- haijiao zhao
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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安慰剂比较：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.
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Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and Clinical Characteristics of Oral Mucosal Ulcers
大体时间：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)
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Xu Huang, PhD、The Fourth Affiliated Hospital of Zhejiang University School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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