Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
Age range: 18 to 65 years old (including 18 and 65 years old);
Eastern Cooperative Oncology Group performance status of ≤2;
Radiotherapy or concurrent chemoradiotherapy is required;
Allergic constitution (such as those known to be allergic to two or more drugs);
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;
Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
Poor oral hygiene and/or severe periodontal diseases;
Parallel
Placebo oral liquid and mouthwash
DrugPlacebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients
Zishui Daohuo oral liquid combined with Kujiu mouthwash
DrugOral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
Radiotherapy
RadiationOne of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
The duration of severe oral mucositis (RTOG grade≥3)
The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.
The time to onset of severe oral mucositis (RTOG grade≥3)
Time from the first day of radiotherapy to the first determination of SOM.
The duration of any-grade oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
Relief rate of oral mucositis
The proportion of patients whose oral mucositis resolved to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy.
The longitudinal dynamics of salivary microbiota
Unstimulated whole saliva samples will be collected via spitting method at three time points: baseline, mid-term radiotherapy (the week corresponding to 50% completion of the planned radiation fractions), and the end of radiotherapy (the final week of RT). 16S rRNA gene sequencing will be performed to assess alterations in the oral microbiota.
Analysis of Inflammatory Indicators in Oral Saliva
Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient oral saliva.
Oral activities scores
Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms.
TCM syndrome score for RIOM
The Radiation-Induced Oral Mucositis Symptom Score Scale is a 17-item patient-reported outcome measure assessing the severity of radiotherapy-related oral mucositis symptoms. The scale covers both oral local manifestations and systemic discomforts. Each item is rated on a 4-point Likert scale (0-3) corresponding to no, mild, moderate, and severe symptoms, respectively. The total score is calculated by summing the scores of all items. Higher total scores indicate greater symptom severity and a heavier symptom burden, whereas lower scores reflect milder symptoms or better symptom relief.
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