nasopharyngeal carcinoma
Conditions
Interventions
treatment:shuanghuabaihe tablets,3#,tid. Since the beginning of chemotherapy
control:placebo,3#,tid.Since the beginning of chemotherapy.
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced nasopharyngeal carcinoma patients who were first diagnosed by pathology; 2. Staging as III, IVa (T1-2N2M0, T3N0-2M0, T4N0-2M0, 2010 AJCC system) by imaging examination (head and neck MRI, chest CT, bone scanning etc); 3. Aged 18-70 years old, all genders; 4. Lesions that can be evaluated by RECIST rule (see appendix 1); 5. no surgery, chemotherapy or radiotherapy history before enrolling; 6. ECOG performance status: 0-2 (see appendix 2); 7. life expectancy >12 months; 8. Laboratory results before chemoradiotherapy must follow: (1) Hepatic function: TB=1.5ULN; AST =2.5ULN and ALT=2.5ULN; ALK=1.5ULN (2) Kidney function: Ccr=80ml/min; (3) Hematologic System: absolute neutrophils count(ANC)=2×10^9/L, blood platelet count=2×10^9/L and hemoglobin (Hb)=9g/dL; (4) Blood sugar level: Good blood glucose control, fasting blood-glucose 3.9-7.2 mmol/L, postprandial blood sugar=10.0mmol/L, HbA1c<7% (Guidelines on prevention and treatment of type II diabetes, 2010); 9. Subjects agree and sign the consent form (If the subject is incompetent to judge the situation, the consent form should be signed by the subject and his/her legal guardian together).count=2×10^9/L and hemoglobin (Hb)=9g/dL;(4) Blood sugar level: Good blood glucose control, fasting blood-glucose 3.9-7.2 mmol/L, postprandial blood sugar=10.0mmol/L, HbA1c<7% (Guidelines on prevention and treatment of type II diabetes, 2010); 10. Subjects agree and sign the consent form (If the subject is incompetent to judge the situation, the consent form should be signed by the subject and his/her legal guardian together).
Exclusion criteria
Exclusion criteria: 1. Anticancer treatment history, including chemotherapy, radiotherapy or surgery; 2. Distant metastasis before treatment; 3. Pregnant or lactating women; 4. Oral mucositis existence before chemoradiotherapy, or recurrent oral mucositis(>1/month); 5. With Periodontitis; 6. Participation in any clinical trial within the preceding 30 days prior to enrollment; 7. Old patients with stomatitis sicca; 8. With severe uncontrolled infections or other medical diseases; 9. With severe cardiac, pulmonary, hepatic dysfunction, such as decompensated cardiac, pulmonary, hepatic dysfunction/failure or poor controlling blood glucose. Patients who are unable to tolerate chemoradiotherapy; 10. Laboratory results: TB=1.5ULN; AST >2.5ULN and/or ALT>2.5ULN; ALK>1.5ULN; 11. Oral therapy is not possible or appropriate; digestive system cannot absorb oral drugs; 12. Some factors may influence drug delivery, distribution, metabolism and excretion, such as insanity, CNS abnormalities, chronic diarrhea, ascites and hydrothorax etc.; 13. Organ transplant patients who are treated by immunosuppressive agent or combined with immunity enhancer for a long-term; 14. With other cancer history prior to enrollment or combined with other malignancies during the course of the study; 15. Cognitive dysfunction, or any condition associated with poor compliance as judged by the investigator; 16. Any subject who are not suitable for enrolling as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and occurrence time of oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration, healing time and healing rate of oral mucositis;The illness severity of oral mucositis in peak and continuous phase;Oral assessment (OAG score);Immunological indicators;Self- assessment in patients; | — |
Countries
China
Contacts
Public ContactGuangying Zhu
Peking University Cancer Hospital
Outcome results
None listed