This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H\&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time,this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Grading standard of RTOG in acute radiation injury of oral mucosal
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time frame: 8 days
The visual analogue scale of oral pain
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time frame: 8 days
EORTCQLQ-H&N35
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time frame: 8 days
patient body weight changes
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Time frame: 8 days
Safety index
Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy
Time frame: 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.