Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid
NCT ID: NCT07311772
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
244 participants
INTERVENTIONAL
2025-12-15
2027-08-15
Brief Summary
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Detailed Description
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At present, conventional clinical prevention and treatment methods include oral hygiene maintenance, epithelial repair-promoting drugs (e.g., recombinant human epidermal growth factor spray, sodium aescinate for injection), and symptomatic supportive care, but there is no universally recognized standard regimen. Houyanqing Oral Liquid is a traditional Chinese medicine preparation composed of Achyranthes aspera L., Kalimeris indica (L.) Sch.-Bip., Plantago asiatica L., and Carpesium abrotanoides L. It possesses the effects of clearing heat and detoxifying, relieving sore throat and pain. Previous studies have confirmed that it exhibits significant efficacy in anti-inflammation, bacteriostasis, and mucosal injury repair, which can shorten the course of oral ulcers and reduce the recurrence rate.
This study intends to conduct a randomized controlled clinical trial to compare the efficacy of Houyanqing Oral Liquid combined with conventional treatment versus conventional treatment alone in preventing RIOM in NPC patients. It aims to verify the advantages of the combined regimen in reducing the incidence of ≥ grade II RIOM, delaying the onset time, alleviating the severity of injury, and improving patients' quality of life, so as to provide a more effective and safe prevention and treatment strategy for RIOM in clinical practice.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Houyanqing Oral Liquid combined with Conventional Treatment
This arm involves Houyanqing Oral Liquid combined with conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients receiving radical radiotherapy. Specific interventions include: 1) Houyanqing Oral Liquid administration before and during radiotherapy; 2) Conventional treatment (same as the control arm): oral hygiene management, epithelial repair promotion, and symptomatic support therapy; 3) Radical radiotherapy (conventional fractionation). The aim is to evaluate the effect of this combined regimen on reducing RIOM severity.
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.
Conventional Treatment
This arm consists of conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients undergoing radical radiotherapy. Specific interventions include: 1) Oral hygiene management; 2) Epithelial repair promotion; 3) Symptomatic support . Patients in this arm will receive radical radiotherapy (conventional fractionation) but will not be administered Houyanqing Oral Liquid.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Fujian Cancer Hospital
OTHER_GOV
Eye & ENT Hospital of Fudan University
OTHER
Zhejiang Cancer Hospital
OTHER
West China Hospital
OTHER
Yunnan Cancer Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
The First People's Hospital of Changzhou
OTHER
Xiangya Hospital of Central South University
OTHER
Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Wuzhou Red Cross Hospital
OTHER
Hunan Cancer Hospital
OTHER
Cancer Hospital of Guangxi Medical University
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Sun Yat-sen University Cancer Centre
UNKNOWN
Cancer Hospital Chinese Academy of Medical Science
UNKNOWN
The Fifth Affiliated Hospital, Sun Yat-sen University
UNKNOWN
Responsible Party
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Ming-Yuan Chen
Professor
Principal Investigators
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Ming-Yuan Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fifth Affiliated Hospital of Sun Yat-sen University
Locations
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Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Fujian Medical University Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhengjiang, China
Countries
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Central Contacts
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Facility Contacts
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Jun-Ling Yi, PhD.
Role: primary
Sufang Qiu
Role: primary
Pei-Yu Huang, MD
Role: primary
Bin Qi
Role: primary
Kai Chen
Role: primary
Ming-Yuan Chen, PhD.
Role: primary
Song Qu
Role: primary
Jin-Hui Liang
Role: primary
Yu-Xiang He
Role: primary
Ya-Qian Han
Role: primary
Wen-Dong Gu
Role: primary
Xiao-Shen Wang
Role: primary
Lei Liu
Role: primary
Zhi-Qiang Wang
Role: primary
Ji-Yong Qin
Role: primary
Feng Jiang
Role: primary
Other Identifiers
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ZDWY-CMY-Houyanqing OL
Identifier Type: -
Identifier Source: org_study_id