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NCT07543978

PHASE3

Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

Official title: Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-04-30

Completion Date

2027-12-31

Last Updated

2026-04-22

Healthy Volunteers

Conditions

Radiotherapy-Induced Oral Mucositis Stomatitis Oral Mucositis Radiotherapy Side Effects

Interventions

DRUG

Modified 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.

DRUG

Placebo 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.

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.

Clinical Research Directory

Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria