Overview

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

Status:
Unknown status
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wei LUO
Treatments:
Hydroxocobalamin
Molgramostim
Pharmaceutical Solutions
Vitamin B 12
Vitamin B Complex
Vitamins
Criteria
Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary
nasopharyngeal carcinoma.

2. Receiving 68-72 Gray of radiation dose.

3. Age between 18 and 65 years.

4. KPS≥70.

5. Patient who has given his/her written consent before any specific procedure of the
protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.

2. Pregnant or breast-feeding females.

3. Allergy to this medicine.

4. Diarrhea.