Clinical trial NCT02303197: Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Official title: A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
chemoradiotherapy
radioactive stomatitis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grading standard of RTOG in acute radiation injury of oral mucosal
timeFrame: 8 days
Secondary outcomes:
measure: The visual analogue scale of oral pain
timeFrame: 8 days
measure: EORTCQLQ-H&N35
timeFrame: 8 days
measure: patient body weight changes
timeFrame: 8 days
measure: Safety index
timeFrame: 2 days
Other outcomes:
measure: IL-6 and TNF- alpha content
timeFrame: 2 days
measure: takes cast-off cells of oral mucosal
timeFrame: 2 days
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: National Clinical Research Center for Cancer of China
name: Cong Wang, Master
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1269/jrr.10069.
citation: Spielberger R. Current management of oral mucositis. Clin Adv Hematol Oncol. 2005 Oct;3(10):769-71. No abstract available.
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.
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.
citation: 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.