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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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