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This study evaluates a traditional Chinese medicine oral liquid and mouthwash, compared with placebo, to help prevent radiation-induced oral mucositis (mouth sores and inflammation) in head and neck cancer patients receiving radiotherapy. Patients aged 18 to 65 with non-metastatic head and neck cancer who are scheduled for radiotherapy or concurrent chemoradiotherapy can take part. It is being carried out in Phase 2 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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).