Evaluation of Spirulina Tablets to Prevent and Treat Radiation-Induced Oral Mucositis and Recurrent Aphthous Stomatitis in Adults

What this Trial Is About

Researchers are evaluating the use of spirulina supplementation to reduce radiation-induced oral mucositis RIOM in patients undergoing radiotherapy for head and neck cancer. This randomized, double-blind, placebo-controlled trial aims to assess whether spirulina tablets, taken alongside standard oral care, can lessen the severity of mouth ulcers caused by radiation treatment. The study also monitors related effects such as oral pain, nutrition, quality of life, treatment interruptions, and any adverse events. Participants will be randomly assigned to receive either spirulina tablets at a dose of 3 g per day 6 tablets daily or matching placebo tablets, starting from the first day of radiotherapy until the treatment is finished. Both groups will continue with standard oral care during the radiotherapy period. The trial compares the effects of spirulina and placebo on oral mucositis severity, incidence, and duration. During the study, participants will undergo daily assessments of oral mucosal ulcers from before intervention up to 14 days, with specific evaluations of oral pain, oral microbiota composition, and salivary biomarkers at baseline, day 7, and day 14. Researchers will track nutritional status, quality of life, treatment compliance, and safety throughout the radiotherapy period. The total participation lasts through the course of radiotherapy and these follow-up assessments.

The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa