Oral Mucositis, Radiotherapy-Induced Oral Mucositis, Radiotherapy Side Effects, Stomatitis
Conditions
Keywords
Radiotherapy-Induced Oral Mucositis, RTOM, Stomatitis, Oral Mucositis, Radiation Injury
Brief summary
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.
Interventions
DRUGModified Dahuang Huanglian Xiexin Mouthwash
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.
DRUGPlacebo Mouthwash
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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 70 years (inclusive) at the time of screening. 2. Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx. 3. Planned to receive radiotherapy. 4. No prior history of radiotherapy to the head and neck region. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. 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 7. Signed written informed consent prior to any study-related procedures. 8. Judged by the investigator to be able to comply with the study protocol. 9. Negative pregnancy test (for women of childbearing potential) at screening. 10. Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
1. Pre-existing oral mucositis prior to the start of radiotherapy. 2. Prior radiotherapy to the head and neck region. 3. Major surgery within 3 weeks prior to enrollment. 4. 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 5. Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment. 6. Active infection requiring systemic therapy. 7. Known history of substance abuse, alcohol abuse, or drug addiction. 8. Pregnancy or breastfeeding. 9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiation-Induced Oral Mucositis Within 2 Weeks of Radiotherapy Initiation | From start of radiotherapy to the 2-week assessment point (day 14 ± 3 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of Radiation-Induced Oral Mucositis | From start of radiotherapy until 7 days after completion of radiotherapy, assessed up to 8 weeks (56 days) from start of radiotherapy. | 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 | 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. | 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 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 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 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 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. |
Contacts
CONTACTChao Wan
Outcome results
None listed