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 range18 Years

SexALL

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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).

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