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Recruiting Phase 2 NCT07282483

Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

Trial Parameters

Condition Radiation-induced Oral Mucositis
Sponsor West China Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 118
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2026-03-16
Completion 2026-08-31
Interventions
Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwashPlacebo oral solution and mouthwashradiotherapy

Brief Summary

Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies

Eligibility Criteria

Inclusion Criteria: 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Age range: 18 to 65 years old (including 18 and 65 years old); 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Radiotherapy or concurrent chemoradiotherapy is required; 5. The main organ functions well; 6. Sign informed consent. Exclusion Criteria: 1. Allergic constitution (such as those known to be allergic to two or more drugs); 2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy; 3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 4. Poor oral hygiene and/or severe periodontal diseases; 5. History of head and neck radiotherapy; 6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

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