Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid

NCT07311772 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Phase 3

Started

2025-12-16

Last updated

2026-05-07

Condition(s) studied

Nasopharyngeal Cancinoma (NPC)Radiation-induced Oral Mucositis

Investigational drug(s) / intervention(s)

Houyanqing Oral LiquidConventional Treatment for Radiation-Induced Oral Mucositis

Houyanqing Oral Liquid: 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.

Conventional Treatment for 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. 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); 2. Age: 18 to 75 years old; 3. Karnofsky Performance Status (KPS) score ≥ 80 before treatment; 4. No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy; 5. Requiring radical radiotherapy; 6. 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 Criteria: 1. Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments; 2. Previous history of head and neck radiotherapy; 3. Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs); 4. 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; 5. Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local use of corticosteroids at immunosuppressive doses before enrollment; 6. HIV-positive patients; 7. Pregnant women or lactating women; 8. Patients with severe mental illnesses; 9. Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.

Primary outcome measure(s)

Incidence of ≥ Grade II radiation-induced oral mucositis — From the start of radical radiotherapy to the 3 months after the completion of radiotherapy
The proportion of patients in the group who develop Grade II or above radiation-induced oral mucositis from the start of radiotherapy. The degree of oral mucosal damage is evaluated according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) diagnostic and grading criteria for radiation-induced oral mucositis.

Trial sites (16)

Facility	City	Region	Status
Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing Municipality	Recruiting
Fujian Medical University Cancer Hospital	Fuzhou	Fujian	Recruiting
Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	Recruiting
Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Guangzhou	Guangdong	Recruiting
Cancer Hospital of Shantou University Medical College	Shantou	Guangdong	Recruiting
Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong	Recruiting
Cancer Hospital of Guangxi Medical University	Nanning	Guangxi	Recruiting
Wuzhou Red Cross Hospital	Wuzhou	Guangxi	Recruiting
Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
Hunan Cancer Hospital	Changsha	Hunan	Recruiting
The First People's Hospital of Changzhou	Changzhou	Jiangsu	Recruiting
Eye & ENT Hospital of Fudan University	Shanghai	Shanghai Municipality	Recruiting
West China Hospital of Sichuan University	Chengdu	Sichuan	Recruiting
The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	Recruiting
Yunnan Cancer Hospital	Kunming	Yunnan	Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhengjiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07311772 on ClinicalTrials.gov ↗ ← All trials in China