This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).
Participants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.
Aged 18 to 70 years (inclusive) at the time of screening.
Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.
Planned to receive radiotherapy.
No prior history of radiotherapy to the head and neck region.
Pre-existing oral mucositis prior to the start of radiotherapy.
Prior radiotherapy to the head and neck region.
Major surgery within 3 weeks prior to enrollment.
Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
Parallel
Modified Dahuang Huanglian Xiexin Mouthwash
DrugA Chinese herbal mouthwash formulation derived from the classic formula Dahuang Huanglian Xiexin Decoction, with additional ingredients to enhance its properties for radiation-induced oral mucositis. The active ingredients include Rhei Radix et Rhizoma, Coptidis Rhizoma, Scutellariae Radix, and other botanical components. It is prepared as a ready-to-use aqueous solution with standardized extraction and quality control procedures. The mouthwash is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing until the development of grade 3 or higher oral mucositis, as defined by the WHO or RTOG criteria. This intervention is distinguished from the placebo comparator by the presence of active herbal ingredients, and its appearance, color, taste, and packaging are matched by the placebo to enable double-blind conditions.
Placebo Mouthwash
DrugA placebo mouthwash formulated to match the active intervention (Modified Dahuang Huanglian Xiexin Mouthwash) in appearance, color, taste, and packaging. It contains no active pharmaceutical ingredients and is composed of purified water with pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the herbal formulation. The mouthwash is supplied as a ready-to-use aqueous solution. It is administered as 10 mL per use, held in the oral cavity for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. This intervention is distinguished from the active comparator by the absence of active herbal ingredients and serves as a control to enable double-blind evaluation.
Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation
Proportion of participants who develop radiation-induced oral mucositis (RTOM) of any grade within 2 weeks after the start of radiotherapy, assessed using the WHO Oral Toxicity Scale or RTOG Acute Radiation Morbidity Scoring Criteria. Participants who develop grade ≥3 RTOM prior to the 2-week assessment point are also counted as having reached the primary endpoint.
Time to Onset of Radiation-Induced Oral Mucositis
Time from the first day of radiotherapy to the first occurrence of any grade of RTOM, as assessed by WHO or RTOG criteria.
Weekly Oropharyngeal Pain Score Measured by OMWQ
Change in oropharyngeal pain and functional impairment assessed weekly using the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN). The OMWQ-HN consists of 12 items assessing mouth and throat soreness, functional limitations, and pain. All item scores are linearly transformed to a 0 to 100 scale, with higher scores indicating worse symptoms and greater functional impairment.
Weekly Body Weight Change During Radiotherapy
Weekly change in body weight (kg) from baseline. Weight is measured at baseline and then weekly throughout the radiotherapy course.
Quality of Life (EORTC QLQ-H&N35)
Weekly change in quality of life scores using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H\&N35). All scale scores range from 0 to 100, with higher scores indicating worse symptoms or lower quality of life. Assessments are performed weekly during the radiotherapy course and again at 4 weeks post-radiotherapy.
Incidence of Intervention-Related Adverse Events
Proportion of participants experiencing at least one adverse event related to the study intervention, assessed using CTCAE version 5.0.
Biomarker Discovery for RTOM Prediction
Collection of biological samples (blood, saliva, stool, urine) for exploratory analysis to identify and validate predictive biomarkers for radiation-induced oral mucositis.
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