Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Houyanqing Oral Liquid
- Conventional Treatment for Radiation-Induced Oral Mucositis
Treatment groups
386 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Fujian Cancer Hospital
Collaborator
Eye & ENT Hospital of Fudan University
Collaborator
Zhejiang Cancer Hospital
Collaborator
West China Hospital
Collaborator
Yunnan Cancer Hospital
Collaborator
First Affiliated Hospital of Kunming Medical University
Collaborator
The First People's Hospital of Changzhou
Collaborator
Xiangya Hospital of Central South University
Collaborator
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Hunan Cancer Hospital
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Cancer Hospital Chinese Academy of Medical Science
Collaborator
The Fifth Affiliated Hospital, Sun Yat-sen University
Collaborator
Source ClinicalTrials.gov