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桔梗防治乳腺癌术后蒽环类抗肿瘤药所致心肌损伤的临床研究
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注册号:

Registration number:

ChiCTR-IPR-16009256 

最近更新日期:

Date of Last Refreshed on:

2016-09-23 

注册时间:

Date of Registration:

2016-09-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

桔梗防治乳腺癌术后蒽环类抗肿瘤药所致心肌损伤的临床研究 

Public title:

A Randomized, Double-blind Pacebo-controlled Trial of Cardioprotective Effect of Platycodon Grandiflorum in Early Breast Cancer Patients Treated with Anthracycline-based Themotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

桔梗防治乳腺癌术后蒽环类抗肿瘤药所致心肌损伤的临床研究 

Scientific title:

A Randomized, Double-blind Pacebo-controlled Trial of Cardioprotective Effect of Platycodon Grandiflorum in Early Breast Cancer Patients Treated with Anthracycline-based Themotherapy 

研究课题代号(代码):

Study subject ID:

14401970900 

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:

郝炜 

研究负责人:

刘胜 

Applicant:

Hao Wei 

Study leader:

Liu Sheng 

申请注册联系人电话:

Applicant telephone:

+86 13524670513 

研究负责人电话:

Study leader's telephone:

+86 18917763005 

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:

hwshtcm@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lshtcm@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.longhua.net/ 

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:

上海市徐汇区宛平南路725号3号楼7楼中西结合乳腺科医生办公室 

研究负责人通讯地址:

上海市徐汇区宛平南路725号3号楼7楼中西结合乳腺科医生办公室 

Applicant address:

725 South Wanping Road, Xuhui District, Shanghai 

Study leader's address:

725 South Wanping Road, Xuhui District, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

200032 

研究负责人邮政编码:

Study leader's postcode:

200032 

申请人所在单位:

上海中医药大学附属龙华医院 

Applicant's institution:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

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:

2015LCSY14 

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:

上海中医药大学附属龙华医院医学伦理委员会 

Name of the ethic committee:

Ethic committee of Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-02-22 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海中医药大学附属龙华医院 

Primary sponsor:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市徐汇区宛平南路725号 

Primary sponsor's address:

725 South Wanping Road, Xuhui District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

具体地址:

上海市徐汇区宛平南路725号

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Address:

725 South Wanping Road, Shanghai

经费或物资来源:

上海市科学技术委员会 

Source(s) of funding:

Science and technology commission of Shanghai Municipality 

研究疾病:

乳腺癌 

Target disease:

Breast Cancer 

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:

上市后药物 

Study phase:

研究目的:

在中医理论的指导下,通过对患者用药前后心脏功能的评估,评价桔梗预防乳腺癌蒽环类化疗药物心脏毒性的临床疗效及其安全性,丰富和发展中医药的防治手段,建立疗效确切、证据确凿、符合中医临床实际的规范的治疗方案,促进其在临床上的应用和推广。 

Objectives of Study:

Under the guidance of the theory of traditional Chinese medicine, evaluating cardioprotective effect and safety of Platycodon grandiflorum(Jacq.) in early breast cancer patients treated with anthracycline-based themotherapy to enhance preventing and treatment methods. Established a clearly, evidence based, compliance with the standard of clinical practice of TCM treatment and to promote its application and promotion in clinical. 

药物成份或治疗方案详述:

桔梗 

Description for medicine or protocol of treatment in detail:

Platycodon Grandiflorum 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合乳腺癌的诊断标准,并经病理学确诊;(2)化疗方案含有蒽环类药物;(3)卡氏评分≥60分以上;(4)预计生存期在6个月以上;(5)年龄在20-70岁之间(含20、70岁);(6)心、肝、肾和造血功能基本正常者;(7)既往无蒽环类药物化疗史,且距上次化疗周期1个月以上;(8)自愿参加临床研究,并签署知情同意书。 

Inclusion criteria

(1) Pathological diagnosis for breast cancer; (2) Patients received anthracycline-based themotherapy; (3) KPS score over 60; (4) Expect survival over 6 monthes; (5) Patients aged 20-70years; (6) No severe organic and functional disease; (7) No anthracycline-based chemotherapy history and more than 1 monthe not receiving chemotherapy. (8)Patients willing to paticipate the research and signe the informed consent file. 

排除标准:

(1)治疗前已有心肌缺血损伤史、先天性心脏病、心肌病及心功能不全等病史;(2)肝、肾功能受损(ALT、AST、血清肌酐水平大于正常上限值2倍);(3)合并急性感染;(4)妊娠或哺乳期妇女,精神障碍者;(5)伴有其他恶性肿瘤者;(6)对本研究药物过敏者;(7)正在参加其它药物试验者。 

Exclusion criteria:

(1) Patients have a history of myocardial injury, CHD, myocardosis, cardiac functional insufficiency; (2) ALT, AST, Scr over trouble normal standard; (3) Patients with acute infection; (4) women with pregnancy, planned pregnancy or lactating; (5) Patients have other malingant tumor; (6) Allergic to this study drug; (7) Patients participated in other clinical trials. 

研究实施时间:

Study execute time:

From2014-07-01To 2017-09-30 

征募观察对象时间:

Recruiting time:

From2015-06-01To 2017-03-30 

干预措施:

Interventions:

组别:

干预组

样本量:

60

Group:

Intervention group

Sample size:

干预措施:

桔梗颗粒剂

干预措施代码:

Intervention:

Platycodon Grandiflorum granules

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三级甲等 

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

临床心衰

指标类型:

主要指标 

Outcome:

Clinical Heart Failure

Type:

Primary indicator 

测量时间点:

测量方法:

美国纽约心脏协会心功能分级

Measure time point of outcome:

Measure method:

NYHA HF grade standard

指标中文名:

亚临床心衰

指标类型:

次要指标 

Outcome:

Subclinical Heart Failure

Type:

Secondary indicator 

测量时间点:

测量方法:

左心室射血分数

Measure time point of outcome:

Measure method:

LVEF

指标中文名:

心电图

指标类型:

附加指标 

Outcome:

electrocardiogram

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心肌肌钙蛋白I

指标类型:

附加指标 

Outcome:

cardiac troponin I

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

B型钠尿肽

指标类型:

附加指标 

Outcome:

Brain natriuretic peptide

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪常规

指标类型:

副作用指标 

Outcome:

stool routine test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

blood routine examination

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

urine routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

ALT, AST, Cr, BUN

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

副作用指标 

Outcome:

Blood pressure

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸

指标类型:

副作用指标 

Outcome:

Respiration

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

副作用指标 

Outcome:

Temperature

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹部超声

指标类型:

副作用指标 

Outcome:

Abdominal ultrasonography

Type:

Adverse events 

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:

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:

尿

组织:

Sample Name:

Urine

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:

组织:

Sample Name:

Stool

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 70 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

通过SPSS19.0进行均衡随机设计分组

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

SPSS 19.0 was used for Balanced randomized design

盲法:

(1)研究者严格按照随机的原则入组受试者,尽量使临床研究处于盲态;(2)尽量使受试者分别接受治疗,使受试者处于盲态;(3)血液检测及数据分析及统计者为非临床研究人员。

Blinding:

The clinical researchers will strictly abide by the studys random design and will avoid Communicating among the patients in each group.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

通过ResMan提供原始数据查询

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

IPD will be public accessable via ResMan

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:

上海中医药大学附属龙华医院 医院管理信息系统(THIS 5.0)

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

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine THIS 5.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-23
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