NCT02303197

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	ChiNing decoction	ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-11-27
• Last updated: 2015-12-22

Locations

1 site across 1 country: China