Radiation oral/ oropharyngeal mucositis in concurrent chemoradiotherapy for nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:'Xiansen Decoction' formula granule combined with radiotherapy and chemotherapy
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age >= 18 years, = 3 months; 7. Subjects are willing to comply with the protocol, able to use the medication as prescribed, accept being followed up regularly, and have good compliance; 8. Subjects can complete questionnaires on their own or with assistance; 9. Subjects have all laboratory tests performed during the screening period as required by the protocol and need to be performed within 14 days before the first dose of the drug. Laboratory test results performed for screening must meet the following criteria; 1) Adequate bone marrow function, hematology: white blood cell count >= 4 X 10^12/L; neutrophil count >= 1.5 X 10^12/L; platelet count >= 100 X 10^9/L; hemoglobin >= 90 g/L; 2) Blood biochemical examination: normal liver function (or AST, ALT = 60 mL/min); normal coagulation function (APTT <= 1.5 times the upper limit of normal value) with INR or PT <= 1.5 times the upper limit of normal values (not on anticoagulation)).
Exclusion criteria
Exclusion criteria: 1. Subjects who have received radiotherapy, chemotherapy, or other antitumor therapy (except those using a limited induction regimen) before the start of the clinical trial 2. Subjects who have had or currently have other tumors whose primary site or histology is not the same as the tumors evaluated in this study Except cervical carcinoma in situ, cured basal cell carcinoma, bladder surface tumors [Ta, Tis & T1], or any cured tumor more than 3 years from study entry. 3. Women who are planning to have children within 1 year as well as those who are pregnant or breastfeeding 4. Subjects who are unable to complete concurrent radiotherapy or delay treatment for more than 1 week due to subjective factors 5. Subjects who have had or are currently suffering from severe oral disease or salivary gland disease 6. Subjects with residual oral/oropharyngeal mucositis healed for less than 1 week after induction chemotherapy 7. Subjects who suffered uncontrolled concurrent disease, including but not limited to poorly controlled diabetes mellitus, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or psychiatric disease 8. Subjects who take long-term oral administration of non-steroidal anti-inflammatory drugs, steroids, and other analgesic drugs 9. Subjects with mental illness, alcoholism, inability to quit smoking, drug addiction or drug abuse, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute radiation oral / oropharyngeal mucositis of grade ? and above; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of occurrence of acute radiation oral / oropharyngeal mucositis of grade ? and above;Oral evaluation guidance (OAG) score;Incidence of acute radiation oral/oropharyngeal mucositis of each grade ;Planned completion rate of concurrent radiotherapy and chemotherapy;Quality of life QLQ-C30 score;NRS pain score;The first occurrence of acute radiation oral/oropharyngeal mucositis; | — |
Countries
China
Contacts
Public ContactLin Lizhu
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed