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The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Summary
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.
Official title: The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-06-01
Completion Date
2028-07-01
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Spirulina Tablets
Spirulina 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
Matching placebo tablets will be administered at 6 tablets daily from the first day of radiotherapy until completion of radiotherapy.
Locations (1)
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China