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

Sichuan University

Status and phase: Enrolling; Phase 2

Conditions: Radiation-induced Oral Mucositis

Treatments: Drug: Spray of spirulina derivatives; Drug: Spray of placebo; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07040969

2025(1088)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
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 Gy with/without concurrent chemotherapy;
5. Sign informed consent.

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 of the 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 other severe diseases).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Spray of placebo

Treatment:

Radiation: Radiotherapy

Drug: Spray of placebo

Experimental group

Experimental group

Description:

Spray of spirulina derivatives

Treatment:

Radiation: Radiotherapy

Drug: Spray of spirulina derivatives