Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid
A Randomized Controlled Study of Houyanqing Oral Liquid Combined With Conventional Treatment Versus Conventional Treatment Alone for Preventing and Treating Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma
Sun Yat-sen University
244 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
Summary
To explore the efficacy of Houyanqing Oral Liquid combined with conventional treatment in preventing and treating radiation-induced oral mucositis, so as to improve the quality of life of nasopharyngeal carcinoma patients received radiotherapy.
Eligibility
Inclusion Criteria6
- Staged as Stage I-IV according to the 9th edition of the TNM Classification of Malignant Tumors formulated by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC);
- Age: 18 to 75 years old;
- Karnofsky Performance Status (KPS) score ≥ 80 before treatment;
- No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy;
- Requiring radical radiotherapy;
- The patient has signed the informed consent form and is willing and able to comply with the study's follow-up visits, treatment plan, laboratory tests, and other research procedures.
Exclusion Criteria9
- Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments;
- Previous history of head and neck radiotherapy;
- Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs);
- Local use of Houyanqing Oral Liquid, Recombinant Human Epidermal Growth Factor (rhEGF) Topical Solution, Vitamin B12 Solution, or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) mouthwash in the oral cavity within one month before enrollment;
- Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local use of corticosteroids at immunosuppressive doses before enrollment;
- HIV-positive patients;
- Pregnant women or lactating women;
- Patients with severe mental illnesses;
- Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.
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Interventions
Houyanqing Oral Liquid is a Chinese herbal preparation formulated with Achyranthes aspera L., Kalimeris indica (L.) Sch.-Bip., Plantago asiatica L., and Carpesium abrotanoides L.. For this study, it is used in nasopharyngeal carcinoma patients receiving radical radiotherapy: the dosage is 10mL per administration, 4 times daily. The medication is initiated prior to radiotherapy and continued until the completion of radiotherapy, with the purpose of preventing and treating radiation-induced oral mucositis.
This intervention refers to the conventional management measures for radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients undergoing radical radiotherapy, including three modules: 1) Oral hygiene management; 2) Epithelial repair promotion; 3) Symptomatic support. These measures are implemented throughout the radiotherapy period to alleviate RIOM-related symptoms.
Locations(16)
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NCT07311772