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临床试验/NCT05059613
NCT05059613Unknown不适用

Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

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: 2021年9月20日最近更新:
适应症

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 variaty of immune index

研究概览

简要总结

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

详细描述

Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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

结局指标

主要结局

the variaty of immune index

时间窗: one month

CD3,CD4,CD8

the incidence of Radiation Therapy Oncology Group grade 3 mucositis

时间窗: one month

Radiation oral mucositis

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
Sponsor

研究点 (1)

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