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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Aphthous Stomatitis; Mouth Ulcer
• Intervention / Treatment: Dietary supplement: Spirulina Tablets; Other: Placebo Tablets

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haijiao Zhao, Master's Student; Phone Number: 13858107163; Email: zhaohaijiao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: haijiao zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.; Other Names: Spirulina
Placebo Comparator: 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.	Other: Placebo Tablets; Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.; Other Names: Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Clinical Characteristics of Oral Mucosal Ulcers	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)	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	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	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.

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Xu Huang, PhD, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Radiation-induced oral mucositis Recurrent aphthous stomatitis Oral ulcer Spirulina Oral microbiota Saliva biomarkers Supportive care
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Oral Ulcer; Stomatitis, Aphthous
• Other Study ID Numbers: KY-2026-085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No