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

NCT07723612 | Recruiting

• 1 other identifier: KY-2026-085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Aphthous Stomatitis; Mouth Ulcer

Keywords

Radiation-induced oral mucositis Recurrent aphthous stomatitis Oral ulcer Spirulina Oral microbiota Saliva biomarkers Supportive care

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

Spirulina Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Spirulina Tablets DIETARY_SUPPLEMENT

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.

Also known as: Spirulina

Spirulina Group

Placebo Tablets OTHER

Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.

Also known as: Matching placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Stomatitis, Aphthous; Oral Ulcer

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Xu Huang, PhD

  The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haijiao Zhao, Master's Student

CONTACT

13858107163; zhaohaijiao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in parallel to receive either spirulina tablets or matching placebo in addition to standard oral care during radiotherapy.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)