Clinical trial · Interventional
Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
NCT07040969CI-TRIAL-00107509active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Spray of placebo | Drug | — | UNRESOLVED |
| Spray of spirulina derivatives | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Spray of placebo
- interventionNames
- Drug: Spray of placebo
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Spray of spirulina derivatives
- interventionNames
- Drug: Spray of spirulina derivatives
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Aged ≥ 18 years; 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Receiving definitive RT or postoperative adjuvant RT at a dose of 60- 72 Gy with/without concurrent chemotherapy; 5. Sign informed consent. Exclusion Criteria: 1. Patients with known allergy to Spirulina components or severe allergic constitution; 2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 3. Poor oral hygiene and/or severe periodontal diseases; 4. History of head and neck radiotherapy; 5. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
References
Publications (0)
Data not yet available
No reference posted for this study.