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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
The First People's Hospital of Changzhou
RECRUITING
Changzhou
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Medical University Cancer Hospital
RECRUITING
Fuzhou
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Yunnan Cancer Hospital
RECRUITING
Kunming
Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Wuzhou Red Cross Hospital
RECRUITING
Wuzhou
Fifth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Ming-Yuan Chen, MD, PhD
chmingy@mail.sysu.edu.cn
86-13903052650
Backup
Yan-Rou Xie, MD
292352606@qq.com
86-13751762936
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2027-08-15
Participants
Target number of participants: 244
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hunan Cancer Hospital, Wuzhou Red Cross Hospital, Cancer Hospital of Guangxi Medical University, Sun Yat-Sen University Cancer Center, West China Hospital, Eye & ENT Hospital of Fudan University, Yunnan Cancer Hospital, First Affiliated Hospital of Kunming Medical University, The Fifth Affiliated Hospital, Sun Yat-sen University, Xiangya Hospital of Central South University, Cancer Hospital Chinese Academy of Medical Science, The First People's Hospital of Changzhou, Affiliated Cancer Hospital of Shantou University Medical College, Zhejiang Cancer Hospital, Fujian Cancer Hospital, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Leads: Sun Yat-sen University