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

Wei LUO

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Cancers

Treatments: Drug: Compound Vitamin B12; Drug: rhGM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT01806272

L-12-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Arm A

Experimental group

Description:

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.

Treatment:

Drug: rhGM-CSF

Drug: Compound Vitamin B12

Arm B

Active Comparator group

Description:

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.

Treatment:

Drug: Compound Vitamin B12