Status:
UNKNOWN
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
Lead Sponsor:
Wei LUO
Conditions:
Nasopharyngeal Cancers
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
- Receiving 68-72 Gray of radiation dose.
- Age between 18 and 65 years.
- KPS≥70.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Exclusion
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01806272
Start Date
March 1 2013
End Date
August 1 2014
Last Update
March 29 2013
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060