Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

Last updated: April 5, 2026
Sponsor: West China Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Mucositis

Treatment

Radiotherapy

Spray of spirulina derivatives

Spray of placebo

Clinical Study ID

NCT07040969
2025(1088)
  • Ages > 18
  • All Genders

Study Summary

To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients pathologically diagnosed with non-metastatic head and neck malignanttumors;

  2. Aged ≥ 18 years;

  3. Eastern Cooperative Oncology Group performance status of ≤2;

  4. Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gywith/without concurrent chemotherapy;

  5. Sign informed consent.

Exclusion

Exclusion Criteria:

  1. Patients with known allergy to Spirulina components or severe allergic constitution;

  2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month ofthe study;

  3. Poor oral hygiene and/or severe periodontal diseases;

  4. History of head and neck radiotherapy;

  5. Deemed unsuitable for the study by the investigators (concomitant with any othersevere diseases).

Study Design

Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Radiotherapy
Phase: 2
Study Start date:
June 27, 2025
Estimated Completion Date:
April 30, 2026

Study Description

The goal of this clinical trial is to evaluate the efficacy and safety of spirulina-derived product in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The study primarily aims to address two questions: (1) whether spirulina-derived product can effectively prevent and mitigate radiation-induced oral mucositis, and (2) whether its use is associated with adverse events in patients undergoing radiotherapy.

Participants will be instructed to orally administer the spirulina-derived product or placebo spray four times daily, starting from the first day of radiotherapy (RT) and continuing throughout the RT course. After each spray application, patients must refrain from eating, drinking, or performing oral hygiene activities for at least 1 hour to maximize mucosal contact time of the intervention.

The study will compare the spirulina-derived product group with the placebo group to determine the potential benefits of this spirulina-based intervention in preventing and managing radiotherapy-related oral mucositis.

Connect with a study center

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

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