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益生菌对乳腺癌患者肿瘤相关认知功能障碍的防治作用及其机制研究
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注册号:

Registration number:

ChiCTR-INQ-17014181 

最近更新日期:

Date of Last Refreshed on:

2019-02-25 

注册时间:

Date of Registration:

2017-12-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

益生菌对乳腺癌患者肿瘤相关认知功能障碍的防治作用及其机制研究 

Public title:

The effect of Probiotics on preventing patients with breast cancer from cancer-related cognitive impairmentand and its mechanism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

益生菌对乳腺癌患者肿瘤相关认知功能障碍的防治作用及其机制研究 

Scientific title:

The effect of Probiotics on preventing patients with breast cancer from cancer-related cognitive impairmentand and its mechanism 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

张娟 

研究负责人:

童建斌 

Applicant:

Zhang Juan 

Study leader:

Tong Jianbin 

申请注册联系人电话:

Applicant telephone:

+86 13908459893 

研究负责人电话:

Study leader's telephone:

+86 15386429820 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

17877272@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

498836726@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院 

研究负责人通讯地址:

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院 

Applicant address:

138 Tongzipo Road, Changsha, Hunan, China 

Study leader's address:

138 Tongzipo Road, Changsha, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中南大学湘雅医学院 

Applicant's institution:

Xiangya Medical College, Cental South University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

R18007 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中南大学湘雅三医院伦理委员会医学伦理分委员会 

Name of the ethic committee:

Medical Ethics Committee Branch of Xiangya Medical College, Cental South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-04-18 

伦理委员会联系人:

黄志军、王晓敏 

Contact Name of the ethic committee:

Huang Zhijun, Wang Xiaomin 

伦理委员会联系地址:

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院 

Contact Address of the ethic committee:

Medical Ethics Committee Branch, 138 Tongzipo Road, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0731 88618938 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xy3irb@163.com 

研究实施负责(组长)单位:

湘雅三医院 

Primary sponsor:

The 3rd hospital of Xiangya 

研究实施负责(组长)单位地址:

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院 

Primary sponsor's address:

138 Tongzipo Road, Changsha, Hu'nan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湘雅三医院

具体地址:

湖南省长沙市岳麓区桐梓坡路138号湘雅三医院

Institution
hospital:

The 3rd hospital of Xiangya

Address:

138 Tongzipo Road, Changsha, Hunan, China

经费或物资来源:

高校科研经费 

Source(s) of funding:

research funding 

研究疾病:

肿瘤相关认知功能障碍 

Target disease:

cancer-related cognitive impairmentand 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.检测益生菌是否能够对乳腺癌患者肿瘤相关认知功能障碍起到防治作用;2.探讨益生菌对乳腺癌患者肿瘤相关认知功能障碍防治作用的可能机制。 

Objectives of Study:

1. To find out wether probiotics can prevent patients with breast cancer from cancer-related cognitive impairmentand; 2. To study the mechanism of how probiotics prevent patients with breast cancer from cancer-related cognitive impairmentand. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

1.新确诊的乳腺癌患者(约500例); 2.年龄20-60岁之间; 3.愿意并能配合实验者。 

Inclusion criteria

1. Newly diagnosed breast cancer patients (about 500 cases); 2. Aged 20-60 years; 3. Willing and able to cooperate with the experimenter. 

排除标准:

1.颅脑外伤、脑出血、脑卒中、脑肿瘤、脑梗死等疾病史; 2.患有冠心病、心梗以及心脏功能极差者; 3.严重肝、肾疾病患者; 4.晚期患者或伴发其他恶性肿瘤患者; 5.存在精神疾病或有精神疾病家族史者; 6.患有PD及AD或已经存在认知功能障碍的患者; 7.嗜酒或吸毒患者; 8.拒绝入组及无法配合治疗者。 

Exclusion criteria:

1. The history of brain injury, cerebral hemorrhage, stroke, brain tumor, cerebral infarction, etc. 2. Patients with coronary heart disease, heart attack and cardiac function; 3. Patients with severe liver and kidney disease; 4. Patients with advanced disease or with other malignant tumors; 5. Family history of mental illness or mental illness; 6. Patients with PD and AD or already had cognitive impairment; 7. Alcoholic or drug addicts; 8. Refused entry and unable to cooperate with the healer. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-11-30 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2019-11-30 

干预措施:

Interventions:

组别:

益生菌组

样本量:

81

Group:

probiotics group

Sample size:

干预措施:

益生菌

干预措施代码:

Intervention:

probiotics

Intervention code:

组别:

对照组

样本量:

81

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湘雅医院 

单位级别:

三甲医院 

Institution
hospital:

Xiangya Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

认知功能

指标类型:

主要指标 

Outcome:

cognitive

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

feces

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 60 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由值班护士按照患者入院顺序先后单双数随机分为两组。

Randomization Procedure (please state who generates the random number sequence and by what method):

The nurses in the hospital divid the patients into two groups according to the order of patients admitted.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成6个月后采用中南大学湘雅三医院科研平台公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

www.xy3yy.com

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

采用CRF进行采集和管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

using CRF to collect the data

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-27
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