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

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: ChiNing decoction

• Registration Number: NCT02303197
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-10
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-20
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChiNing decoction	ChiNing decoction	60ml ChiNing decoction by mouth，three times a day for 46 days.

Primary Outcome Measures

Name	Time	Method
Grading standard of RTOG in acute radiation injury of oral mucosal	8 days	Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy

Secondary Outcome Measures

Name	Time	Method
The visual analogue scale of oral pain	8 days	Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
EORTCQLQ-H&N35	8 days	Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
patient body weight changes	8 days	Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
Safety index	2 days	Chech the blood routine, urine routine, liver and kidney function, electrocardiogram before and after the radiotherapy

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China