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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The incidence of grade II and less oral mucositis at the end of treatment
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patient who has given his/her written consent before any specific procedure of the protocol.
排除标准
- •Severe uncontrolled infection.
- •Pregnant or breast-feeding females.
- •Allergy to this medicine.
研究组 & 干预措施
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.
干预措施: rhGM-CSF (Drug)
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.
干预措施: Compound Vitamin B12 (Drug)
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.
干预措施: Compound Vitamin B12 (Drug)
结局指标
主要结局
The incidence of grade II and less oral mucositis at the end of treatment
时间窗: 7 weeks
Using the criteria of NCI CTCAE v3.0
次要结局
- Pain(12 weeks)
- Cumulative incidence and time of grade III and more oral mucositis(7 weeks)
- Dysphagia(12 weeks)
- Tumor response to chemoradiotherapy(12 weeks)
研究者
Wei LUO
Professor
Sun Yat-sen University