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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.
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 timeļ¼this 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChiNing decoction | Experimental | 60ml ChiNing decoction by mouthļ¼three times a day for 46 days. |
|
| rhEGF spray | No Intervention | The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChiNing decoction | Drug | ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 and TNF- alpha content | With distilled water repeatedly rinse of 1 min, 10 min after discarding the first mouthful of saliva, sit down, spit saliva to the sterile tube in 4 Centigradeļ¼ before and after the radiotherapy | 2 days |
| takes cast-off cells of oral mucosal |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cong Wang, Master | National Clinical Research Center for Cancer of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20921827 | Background | Ryu SH, Kang KM, Moon SY, Chai GY, Hong JP, Cho KO, Kang MI, Choi EK, Lee SW. Therapeutic effects of recombinant human epidermal growth factor (rhEGF) in a murine model of concurrent chemo- and radiotherapy-induced oral mucositis. J Radiat Res. 2010;51(5):595-601. doi: 10.1269/jrr.10069. | |
| 16258486 | Background |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
rinse the mouth with the physiological salt water , scrap sides of buccal oral mucosa 2 times appropriate efforts with appropriate effort, painted on a slideļ¼before and after the radiotherapy |
| 2 days |
| Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available. |
| 22679734 | Background | Wang B, Cao SH, Wang YQ. [Effects of modified liangge powder contained serum on LPS stimulated TLR4 expression and release of cytokines in mouse platelets]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 May;32(5):681-4. Chinese. |
| 16573003 | Background | Yu LZ, Jiang AD, Cheng YY, Lin H, Qin QH, Ma XD. [Liangge san effects the expression of CD14 and scaverger receptor in the Kupffer cells of liver of endotoxemia mice]. Zhongguo Zhong Yao Za Zhi. 2006 Feb;31(3):220-3. Chinese. |
| 15958292 | Background | Jiang AD, Yu LZ, Gong XW, Deng P, Ma XD. [Effect of Liangge San on lipopolysaccharide-induced nuclear factor kappa B activation in cultured mouse macrophages]. Di Yi Jun Yi Da Xue Xue Bao. 2005 Jun;25(6):619-22. Chinese. |