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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303197
• Other study ID #: TianjinCIH
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2014
• Last updated: December 20, 2015
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Stomatitis

Intervention

Drug:
• ChiNing decoction
ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 Centigrade, before and after the radiotherapy	2 days	No
Other	takes cast-off cells of oral mucosal	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	2 days	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Safety index	Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy	2 days	No