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临床试验/NCT03112837
NCT03112837Unknown不适用

Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

Jiangxi Provincial Cancer Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
the incidence of Radiation Therapy Oncology Group grade 3 mucositis

研究概览

简要总结

Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

详细描述

Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy.It can lead to dose-limiting and debilitating side effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In the mucosa, the immune system's T cells and B cells have position-specific phenotypes and functions that are influenced by the microbiota. These cells play pivotal parts in the maintenance of immune homeostasis by suppressing responses to harmless antigens and by enforcing the integrity of the barrier functions of the gut mucosa.We designed a randomized trial of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules in patients with Nasopharyngeal Carcinoma. The aim of this study was to determine if regulating intestinal tract flora was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis.In 2017, 40 patients are estimated to be recruited into the study at Jiangxi Cancer Hospitals, China.20 patients were randomized to receive Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules and 20 to receive a placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Karnofsky score ≥80 newly diagnosed NPC without distant metastasis confirmed by pathology without any other malignant disease history no any other anti-cancer treatment for NPC previously received radiotherapy and chemotherapy at our Cancer Center

排除标准

  • •any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease

研究组 & 干预措施

drug group

Experimental

live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy

干预措施: Lactobacillus, Bifidobacterium and Enterococcus (Other)

non-drug group

No Intervention

only receiving radiotherapy and chemotherapy

healthy control group

No Intervention

结局指标

主要结局

the incidence of Radiation Therapy Oncology Group grade 3 mucositis

时间窗: one year

confluent pseudomembranous mucosa

次要结局

未报告次要终点

研究者

发起方
Jiangxi Provincial Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiang Xu

head of Science and Euducation Division

Jiangxi Provincial Cancer Hospital

研究点 (1)

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