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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Recurrent Aphthous Stomatitis, Mouth Ulcer

In brief

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.

Key facts

Study ID

NCT07723612

Run by

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

People needed

40

Starts

2026-06-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Willing and able to comply with all study procedures, follow-up visits, and assessments.

You may not qualify if…

• 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.
• Participation in another interventional clinical trial during the study period.
• Any condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.

Where it is running

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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