Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: ChiNing decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and neck cancer patients with pathology and / or cytologic diagnosis; Age 18 75 years old; The expected life is more than 3 months; The Karnofsky score (Karnofsky) ≥70 points; The first course of radiotherapy in patients; Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system; Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme; No history of oral ulcer and salivary gland diseases Exclusion Criteria: That do not meet the above the inclusion criteria; Advanced critical cases, the expected survival is less than 3 months; The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal; The submandibular gland pathological changes; During radiotherapy taking other drugs in patients with treatment of stomatitis; The patients with serious heart, brain, liver, kidney function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ChiNing decoction<br>60ml ChiNing decoction by mouth，three times a day for 46 days. | Drug: ChiNing decoction<br>* ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.<br>* Other names: Addition and subtraction of Liangge San;|
| No Intervention: rhEGF spray<br>The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 8 days | 
| Safety index | Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, chemoradiotherapy, radioactive stomatitis