Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ChiNing decoction 60ml ChiNing decoction by mouth，three times a day for 46 days. |
Drug: ChiNing decoction
ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
Other Names:
|
| No Intervention: rhEGF spray The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days. |
Outcome Measures
Primary Outcome Measures
- Grading standard of RTOG in acute radiation injury of oral mucosal [8 days]
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Secondary Outcome Measures
- The visual analogue scale of oral pain [8 days]
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
- EORTCQLQ-H&N35 [8 days]
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
- patient body weight changes [8 days]
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
- Safety index [2 days]
Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy
Other Outcome Measures
- IL-6 and TNF- alpha content [2 days]
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 Centigrade， before and after the radiotherapy
- takes cast-off cells of oral mucosal [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 slide，before and after the radiotherapy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Head and neck cancer patients with pathology and / or cytologic diagnosis;
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Age 18~75 years old;
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The expected life is more than 3 months;
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The Karnofsky score (Karnofsky) ≥70 points;
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The first course of radiotherapy in patients;
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Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
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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;
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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;
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The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | 300060 |
Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
- Principal Investigator: Cong Wang, Master, National Clinical Research Center for Cancer of China
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71.
- 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.
- 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.
- TianjinCIH