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
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
Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
DrugClassical traditional Chinese medicine (TCM) formulations provided as an oral liquid and a herbal mouthwash
Placebo oral solution and mouthwash
DrugA placebo matched in color, odor, and taste to the Qingying oral liquid and the modified Da Huang-Huang Lian Xiexin mouthwash, but containing no active medicinal ingredients.
radiotherapy
RadiationAll subjects underwent radical radiotherapy
Incidence rate 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.
Duration of mild-to-moderate RIOM
Time from the first documentation of RTOG grade 1-2 oral mucositis during radiotherapy to the first return to RTOG grade 0 (no mucositis) sustained for ≥48 hours.
The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
RIOM remission rates at 4 and 8 weeks after completion of radiotherapy
The proportion of participants whose oral mucositis has decreased to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy, respectively.
Duration of oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
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.
Mouth and throat soreness (MTS) scores
Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms.
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.
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