NCT01806272

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Wei LUO · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Outcome measures: 1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0 2. Pain: WHO,Numerical Rating Scale(NRS) 3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Conditions

• Nasopharyngeal Cancers

Interventions

Type	Name	Description
DRUG	rhGM-CSF	The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.
DRUG	Compound Vitamin B12	Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2013-03-07
• Last updated: 2013-03-29

Locations

1 site across 1 country: China