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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.
Inclusion Criteria:
Exclusion Criteria:
Outcome measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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. |
|
| Arm B | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhGM-CSF | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei LUO, M.D. | Contact | +862087343483 | luowei2@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei LUO, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C082856 | regramostim |
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| Compound Vitamin B12 | Drug | Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily |
|
|
| 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 |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |