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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Houyanqing Oral Liquid
DrugHouyanqing 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
Other interventionThis 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.
Treatment groups
386 Participants
are divided into 2 treatment groupsGroup A: Houyanqing Oral Liquid combined with Conventional TreatmentExperimental treatment 2 interventions
Group B: Conventional TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the start of radical radiotherapy to the 3 months after the completion of radiotherapySecondary outcomes
1
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.
Time frame
From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.2
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.
Time frame
From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.3
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.
Time frame
From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy4
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.
Time frame
From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
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