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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: ChiNing decoction

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Addition and subtraction of Liangge San
No Intervention: rhEGF spray; The rhEGF spray spray on the oral mucosal surface irradiated area, 3 times a day for 46 days.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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 Centigrade， before and after the radiotherapy	2 days
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Cong Wang, Master, National Clinical Research Center for Cancer of China

Publications and helpful links

General Publications

• 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.
• Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 20, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: head and neck cancer; chemoradiotherapy; radioactive stomatitis
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Stomatitis
• Other Study ID Numbers: TianjinCIH