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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Placebo Comparator | Placebo mouthwash matching the active intervention in appearance, color, taste, and packaging, containing no active pharmaceutical ingredients. It consists of purified water, pharmaceutical-grade coloring and flavoring agents to mimic the characteristics of the Modified Dahuang Huanglian Xiexin Mouthwash. Patients in this arm are instructed to rinse with 10 mL of the placebo solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as a control to evaluate the efficacy of the active intervention under double-blind conditions. |
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| Experimental arm | Experimental | Modified Dahuang Huanglian Xiexin Mouthwash (Jiawei Dahuang Huanglian Xiexin Koufuye), an active Chinese herbal formulation. Patients in this arm are instructed to rinse with 10 mL of the active solution for 2-3 minutes, six times daily, starting from the first day of radiotherapy and continuing throughout the radiotherapy course. All participants receive the same radiotherapy regimen and standard oral care. This arm serves as the experimental intervention to evaluate its efficacy in reducing radiation-induced oral mucositis compared with a matched placebo under double-blind conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Dahuang Huanglian Xiexin Mouthwash | Drug | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first. |
Inclusion Criteria:
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):
Hemoglobin (Hb) ≥90 g/L Absolute neutrophil count (ANC)≥1.5×10⁹/L Platelet count (PLT) ≥80×10⁹/L Total bilirubin (BIL) < 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) > 50 mL/min
Signed written informed consent prior to any study-related procedures.
Judged by the investigator to be able to comply with the study protocol.
Negative pregnancy test (for women of childbearing potential) at screening.
Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
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.
Uncontrolled cardiac conditions or symptoms, including but not limited to:
New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention
Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.
Active infection requiring systemic therapy.
Known history of substance abuse, alcohol abuse, or drug addiction.
Pregnancy or breastfeeding.
Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Wan | Contact | +86-18062775069 | wanc@hust.edu.cn |
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This is a quadruple-blind study. Participants, care providers, investigators, and outcome assessors are all blinded to group assignment. The placebo mouthwash is identical in appearance, taste, smell, and packaging to the active Modified Dahuang Huanglian Xiexin Mouthwash to ensure successful blinding.
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| Placebo Mouthwash | Drug | A 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. |
|
| 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 from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first. |
| 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. | weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first. |
| 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. | weekly from start of radiotherapy to 7 days post-radiotherapy, assessed up to 56 days, or until occurrence of grade ≥3 RTOM, whichever comes first. |
| 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. |
| Baseline (prior to radiotherapy initiation), week 2 (± 2 days), and completion of radiotherapy (± 3 days). |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
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