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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Haijiao Zhao, Master's Student
- 電話番号：13858107163
- メール：zhaohaijiao@zju.edu.cn
研究場所
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Zhejiang
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Yiwu、Zhejiang、中国、322000
- 募集
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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コンタクト：
- haijiao zhao
-
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence and Clinical Characteristics of Oral Mucosal Ulcers
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Xu Huang, PhD、The Fourth Affiliated Hospital of Zhejiang University School of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KY-2026-085
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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