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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation-induced Oral Mucositis; Nasopharyngeal Cancinoma (NPC)
• Intervention / Treatment: Drug: Houyanqing Oral Liquid; Other: Conventional Treatment for Radiation-Induced Oral Mucositis

Detailed Description

Nasopharyngeal carcinoma (NPC) is a highly prevalent malignant tumor in China. Radical radiotherapy serves as its core treatment modality, yet radiation-induced oral mucositis (RIOM) is the most common adverse reaction of radiotherapy, with an incidence rate as high as 85%-100%, among which 34% of patients develop grade 3-4 mucositis. RIOM can cause oral pain, ulcers, and dysphagia, which not only severely reduce patients' quality of life but also may lead to radiotherapy interruption, increased infection risk, and elevated treatment costs. Therefore, the prevention and treatment of RIOM are of great significance.

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.

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ming-Yuan Chen, MD, PhD; Phone Number: 86-13903052650; Email: chmingy@mail.sysu.edu.cn
• Study Contact Backup: Name: Yan-Rou Xie, MD; Phone Number: 86-13751762936; Email: 292352606@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Science
      • Contact: Jun-Ling Yi, PhD.; Phone Number: +86 13661217998; Email: yijunlin1969@163.com
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Medical University Cancer Hospital
      • Contact: Sufang Qiu; Phone Number: 86-13609589163
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Pei-Yu Huang, MD; Phone Number: 86-18928013516
    • Guangzhou, Guangdong, China, 510095
      • Recruiting
      • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
      • Contact: Bin Qi; Phone Number: 86-13580580985
    • Shantou, Guangdong, China, 515041
      • Recruiting
      • Cancer Hospital of Shantou University Medical College
      • Contact: Kai Chen; Phone Number: 86-13005222990
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Ming-Yuan Chen, PhD.; Phone Number: 86-13903052650; Email: chmingy@mail.sysu.edu.cn
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Cancer Hospital of Guangxi Medical University
      • Contact: Song Qu; Phone Number: 86-13607887386
    • Wuzhou, Guangxi, China, 543002
      • Recruiting
      • Wuzhou Red Cross Hospital
      • Contact: Jin-Hui Liang; Phone Number: 86-13878480806
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Yu-Xiang He; Phone Number: 86-13786112914
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Ya-Qian Han; Phone Number: 86-18673176667
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • The First People's Hospital of Changzhou
      • Contact: Wen-Dong Gu; Phone Number: 86-13861220022
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200031
      • Recruiting
      • Eye & ENT Hospital of Fudan University
      • Contact: Xiao-Shen Wang; Phone Number: 86-18917785187
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Lei Liu; Phone Number: 86-18980606231
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • The First Affiliated Hospital of Kunming Medical University
      • Contact: Zhi-Qiang Wang; Phone Number: 86-15887085161
    • Kunming, Yunnan, China, 650118
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Ji-Yong Qin; Phone Number: 86-13808757779
  • Zhengjiang
    • Hangzhou, Zhengjiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Feng Jiang; Phone Number: 86-13858065192

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ≥ Grade II radiation-induced oral mucositis	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.	From the start of radical radiotherapy to the 3 months after the completion of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of Grade II or above radiation-induced oral mucositis	Time from the first day of radiotherapy to the first occurrence of Grade II or above radiation-induced oral mucositis according to RTOG/EORTC criteria.	From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.
Cumulative radiotherapy dose at onset of Grade II or above radiation-induced oral mucositis	Cumulative radiotherapy dose from the first day of radiotherapy to the first occurrence of Grade II or above radiation-induced oral mucositis according to RTOG/EORTC criteria.	From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.
Remission rate of Grade II or above radiation-induced oral mucositis	The proportion of patients who experience remission from Grade II or above to below Grade II radiation-induced oral mucositis after the first occurrence.	From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy
Complete remission rate of radiation-induced oral mucositis	The proportion of patients who achieve complete remission of Grade II or above radiation-induced oral mucositis after the first occurrence.	From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy
Remission time of Grade II or above radiation-induced oral mucositis	Time from the first occurrence of Grade II or above radiation-induced oral mucositis to remission below Grade II.	From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.
Complete remission time of radiation-induced oral mucositis	Time from the first occurrence of Grade II or above radiation-induced oral mucositis to complete remission.	From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhejiang Cancer Hospital; Wuzhou Red Cross Hospital; Xiangya Hospital of Central South University; Fujian Cancer Hospital; West China Hospital; Hunan Cancer Hospital; Eye & ENT Hospital of Fudan University; Affiliated Cancer Hospital of Shantou University Medical College; Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Yunnan Cancer Hospital; Cancer Hospital of Guangxi Medical University; The First People's Hospital of Changzhou; First Affiliated Hospital of Kunming Medical University; The Fifth Affiliated Hospital, Sun Yat-sen University; Cancer Hospital Chinese Academy of Medical Science; Sun Yat-Sen University Cancer Center
• Investigators: Principal Investigator: Ming-Yuan Chen, MD, PhD, Fifth Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radiation-induced Oral Mucositis; Nasopharyngeal Cancinoma; Houyanqing Oral Liquid
• Other Study ID Numbers: ZDWY-CMY-Houyanqing OL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No