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

Sponsor

Wei LUO (Other)

Overall Status

Unknown status

CT.gov ID

NCT01806272

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Cancers	Drug: rhGM-CSF Drug: Compound Vitamin B12	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A 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 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. Other Names: 特尔立 Drug: Compound Vitamin B12 Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Other Names: 贯新克
Active Comparator: Arm B 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 Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Other Names: 贯新克

Arm

Intervention/Treatment

Experimental: Arm A

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

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.

Other Names:

特尔立

Drug: Compound Vitamin B12

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Other Names:

贯新克

Active Comparator: Arm B

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

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Other Names:

贯新克

Outcome Measures

Primary Outcome Measures

The incidence of grade II and less oral mucositis at the end of treatment [7 weeks]
Using the criteria of NCI CTCAE v3.0

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.