NCT07040969

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

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Radiation-induced Oral Mucositis

Interventions

Type	Name	Description
DRUG	Spray of spirulina derivatives	An oral spray formulated with purified spirulina-derived exosomes.
DRUG	Spray of placebo	The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
RADIATION	Radiotherapy	One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-01-15
• Completion: 2026-04-30
• First posted: 2025-06-27
• Last updated: 2026-04-07

Locations

1 site across 1 country: China