radiation oral/ oropharyngeal mucositis in concurrent chemoradiotherapy for nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Xiansen Decoction 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. Aged 18 to 75 years, male or non-pregnant, lactating female; 2. Histopathology is moderately differentiated or undifferentiated locally advanced nasopharyngeal carcinoma (WHO classification II-III stage). 3. Patients with clinical T3-4N1M0/TxN2-3M0 (version 8 UICC/AJCC staging) who have never received radiotherapy or cytotoxic chemotherapy (single drug or combination, except induction chemotherapy) and immunotherapy. 4. ECOG:0-1; 5. Adequate bone marrow function, hematological examination: 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 >= 9g / L; 6. Blood biochemical examination: normal liver function (or total bilirubin, AST, ALT = 60ml/min1.5 normal value upper limit); 7. The subjects volunteered to join the study and signed an informed consent form with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Received radiotherapy, chemotherapy or other antineoplastic therapy before the start of the clinical trial; (except induction chemotherapy). 2. Those who have or are suffering from other tumors whose primary location or histology are different from those evaluated in this study. Excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder surface tumor [Ta,Tis&T1], or any cured tumors enrolled in any distance for more than 3 years. 3. Patients who have or are suffering from serious oral or salivary gland diseases. 4. Patients are unwilling to stop smoking, drinking and chewing betel nuts and other bad living habits. 5. The patient has other uncontrolled serious diseases at the same time. 6. Abnormal function of heart, brain, lung and other important organs. 7. Patients who are unable to complete concurrent chemoradiotherapy or delayed treatment for more than 1 week due to subjective factors. 8. The researchers believe that there are any other situations that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute radiation oral / oropharyngeal mucositis of grade III and above; | — |
Secondary
| Measure | Time frame |
|---|---|
| Planned completion rate of concurrent radiotherapy and chemotherapy;Quality of life QLQ-C30 and QLQ-H/N 35 score;Acute radiation response oral mucositis classification;Short-term efficacy;Time of occurrence of acute radiation oral / oropharyngeal mucositis of grade III and above;Oral evaluation guidance (OAG) score;NRS pain score; | — |
Countries
China
Contacts
Public ContactLin Lizhu
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Outcome results
None listed