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

Study Overview
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Brief Summary
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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
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Inclusion Criteria: 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 Criteria: Severe uncontrolled infection. Pregnant or breast-feeding females. Allergy to this medicine. Diarrhea. Outcome measures: Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0 Pain: WHO,Numerical Rating Scale(NRS) Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Official Title
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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

Conditions
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Nasopharyngeal Cancers

Intervention / Treatment
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* Drug: rhGM-CSF
* Drug: Compound Vitamin B12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Severe uncontrolled infection. Pregnant or breast-feeding females. Allergy to this medicine. Diarrhea.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Local use of rhGM-CSF + Compound Vitamin B12 solution: 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. Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. | Drug: rhGM-CSF<br>* 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.<br>* Other names: 特尔立;Drug: Compound Vitamin B12<br>* Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily<br>* Other names: 贯新克;|
| Active Comparator: Arm B<br>Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. | Drug: Compound Vitamin B12<br>* Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily<br>* Other names: 贯新克;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of grade II and less oral mucositis at the end of treatment | Using the criteria of NCI CTCAE v3.0 | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Cumulative incidence and time of different grade,using the criteria of WHO,NRS | 12 weeks | 
| Cumulative incidence and time of grade III and more oral mucositis | Using the criteria of NCI CTCAE v3.0 | 7 weeks | 
| Dysphagia | Cumulative incidence and time of different grade,using NCI CTCAE v3.0 | 12 weeks | 
| Tumor response to chemoradiotherapy | Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhGM-CSF, Oral Mucositis, Primary Nasopharyngeal Cancers, Chemoradiotherapy