Spirulina for mouth ulcers during cancer radiotherapy
Official title: The Preventive and Therapeutic Effects of Spirulina Preparations on Recurrent Aphthous Ulcers of the Oral Mucosa
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07723612 · Data updated 2026-11-12
This trial tests whether taking spirulina tablets, alongside standard care, can lessen and shorten mouth ulcers caused by radiotherapy in head and neck cancer patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Yiwu, Zhejiang) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07723612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with radiation-induced oral mucositis or other clinically diagnosed oral ulcers, active at enrollment, and able to provide informed consent.
✕Probably not a fit
Patients with prior head and neck radiotherapy, spirulina allergy, severe comorbidities, or those pregnant or breastfeeding may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind, placebo-controlled study to see if spirulina supplements reduce the severity of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancer. Participants are assigned to spirulina or placebo in addition to standard oral care, with outcomes including mucositis severity, incidence, duration, oral pain, nutrition, quality of life, treatment interruptions, and adverse events. The study aims to determine if spirulina is a safe and effective adjunct to improve supportive care during radiotherapy. Safety monitoring for spirulina is included throughout the trial.
Why it matters
Potential benefit: If successful, spirulina could become a safe, adjunctive option to lessen mucositis and improve quality of life during radiotherapy.
How similar studies have gone: Similar approaches with safe supplements have shown promise in supportive cancer care, but this specific spirulina approach for RIOM is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
-
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Xu Huang, PhD — The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Study coordinator: Haijiao Zhao, Master's Student
- Email: zhaohaijiao@zju.edu.cn
- Phone: 13858107163
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.