Status:
COMPLETED
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02303197
Start Date
May 1 2014
End Date
December 1 2015
Last Update
December 22 2015
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060