The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence and Clinical Characteristics of Oral Mucosal Ulcers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and investigators will be blinded to group assignment. Participants will receive either spirulina tablets or matching placebo tablets in addition to standard oral care during radiotherapy.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence and Clinical Characteristics of Oral Mucosal Ulcers
时间窗: From Day 0 (before intervention) through Day 14, assessed daily.
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.
Oral Pain Intensity (Visual Analog Scale, VAS)
时间窗: Day 0 (before intervention), Day 7, and Day 14.
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.
Oral Microbiota Composition
时间窗: Day 0 (before intervention), Day 7, and Day 14.
Oral microbiota samples were collected for metagenomic sequencing to evaluate changes in microbial composition, microbial diversity, and relative abundance following the intervention.
Salivary Biomarkers
时间窗: Day 0 (before intervention), Day 7, and Day 14.
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.
次要结局
未报告次要终点