Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms - Stomatitis
Conditions: Keywords
head and neck cancer, chemoradiotherapy, radioactive stomatitis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: ChiNing decoction
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: Wang Cong, Master - 86-13752570372 - wangcongalex@126.com
Start Date
May 2014
Completion Date
July 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page