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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Haijiao Zhao, Master's Student
- 전화번호: 13858107163
- 이메일: zhaohaijiao@zju.edu.cn
연구 장소
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Zhejiang
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Yiwu, Zhejiang, 중국, 322000
- 모병
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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연락하다:
- haijiao zhao
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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위약 비교기: 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.
다른 이름들:
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence and Clinical Characteristics of Oral Mucosal Ulcers
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Xu Huang, PhD, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KY-2026-085
개별 참가자 데이터(IPD) 계획
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