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.
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.
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.
Parallel
Spirulina Tablets
Dietary supplementSpirulina tablets will be administered at a dose of 3 g/day (6 tablets daily) from the first day of radiotherapy until completion of radiotherapy.
Placebo Tablets
Other interventionMatching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
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.
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.
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.
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.
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