The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa (NCT07723612) | Clinical Trial Compass
RecruitingNot Applicable
The Preventive and Therapeutic Effects of Spirulina Preparations on Ulcers of Oral Mucosa
China40 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Clinical Characteristics of Oral Mucosal Ulcers
Timeframe: From Day 0 (before intervention) through Day 14, assessed daily.
2
Oral Pain Intensity (Visual Analog Scale, VAS)
Timeframe: Day 0 (before intervention), Day 7, and Day 14.
3
Oral Microbiota Composition
Timeframe: Day 0 (before intervention), Day 7, and Day 14.
4
Salivary Biomarkers
Timeframe: Day 0 (before intervention), Day 7, and Day 14.
Trial details
NCT IDNCT07723612
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine