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
West China Hospital
70 participants
Jun 27, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Aged ≥ 18 years;
- Eastern Cooperative Oncology Group performance status of ≤2;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy;
- Sign informed consent.
Exclusion Criteria5
- Patients with known allergy to Spirulina components or severe allergic constitution;
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Interventions
An oral spray formulated with purified spirulina-derived exosomes.
The placebo oral spray will be formulated with inactive ingredients matched in appearance and flavor profile to the active spirulina-derived product.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07040969