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

21 juli 2026 uppdaterad av: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Zhejiang
      • Yiwu, Zhejiang, Kina, 322000
        • Rekrytering
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:
          • haijiao zhao

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: 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.
Andra namn:
  • Spirulina
Placebo-jämförare: 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.
Övrig: Placebo Tablets
Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
Andra namn:
  • Matchande placebo

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Utredare

  • Huvudutredare: Xu Huang, PhD, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

8 juli 2026

Först inskickad som uppfyllde QC-kriterierna

21 juli 2026

Första postat (Faktisk)

23 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY-2026-085

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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