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.