drugset / Trial / NCT01806272

Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

NCT01806272

Phase 2 Unknown 160 enrolled Wei LUO
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.

Timeline

Start
2013-03
Primary completion
2014-06
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject rhGM-CSF Protein / enzyme biologic 150 ug Other
Background Compound Vitamin B12 Unknown 5 ml Other