A Open,Randomized Phase II Trial Comparing Local Use of rhGM-CSF and Compound Vitamin B12 Solution to Compound Vitamin B12 Solution Alone Treating Chemoradiotherapy-induced Oral Mucositis in Patients With Primary Nasopharyngeal Carcinoma
1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
5. Patient who has given his/her written consent before any specific procedure of the
1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI
2. Pain: WHO,Numerical Rating Scale(NRS)
3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The incidence of grade II and less oral mucositis at the end of treatment
Using the criteria of NCI CTCAE v3.0
Wei LUO, M.D.
Sun Yat-sen University
China: Ethics Committee