Active — Not RecruitingPhase 2

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

China70 participantsStarted 2025-06-27

Plain-language summary

To evaluate the efficacy and safety of Spirulina-Derived Product for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

Who can participate

Age range

18 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

. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
. Aged ≥ 18 years;
. Eastern Cooperative Oncology Group performance status of ≤2;
. Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy;
. Sign informed consent.

Exclusion criteria

. Patients with known allergy to Spirulina components or severe allergic constitution;
. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
. Poor oral hygiene and/or severe periodontal diseases;
. History of head and neck radiotherapy;
. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

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

The incidence of severe oral mucositis (WHO grade ≥3)

Timeframe: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks to 14.5 weeks.

Trial details

NCT IDNCT07040969

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Radiation-induced Oral Mucositis trials