Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
- Registration Number
- NCT01806272
- Lead Sponsor
- Wei LUO
- 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.
- 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.
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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.
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A rhGM-CSF 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 A Compound Vitamin B12 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 Compound Vitamin B12 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China