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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 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.

Clinical Trial 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 timeļ¼Œthis 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

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02303197
Study type Interventional
Source Tianjin Medical University Cancer Institute and Hospital
Contact
Status Completed
Phase Phase 3
Start date May 2014
Completion date December 2015
View Details
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