今天是:2019-12-13 星期五

针刺治疗肺癌相关性疲乏多中心随机对照研究
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注册号:

Registration number:

ChiCTR1900022831 

最近更新日期:

Date of Last Refreshed on:

2019-05-20 

注册时间:

Date of Registration:

2019-04-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针刺治疗肺癌相关性疲乏多中心随机对照研究 

Public title:

Effect of Acupuncture on Lung Cancer-Related Fatigue: A Multi-center Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针刺治疗肺癌相关性疲乏多中心随机对照研究 

Scientific title:

Effect of Acupuncture on Lung Cancer-Related Fatigue: Study Protocol for a Multi-center Randomized Controlled Trial 

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:

AMCTR-IOR-19000272 

申请注册联系人:

王照钦 

研究负责人:

吴焕淦 

Applicant:

Zhaoqin Wang 

Study leader:

Huangan Wu 

申请注册联系人电话:

Applicant telephone:

+86 18621153795 

研究负责人电话:

Study leader's telephone:

+86 13601611239 

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:

dddiannao@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wuhuangan@126.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:

上海市徐汇区宛平南路650号 

研究负责人通讯地址:

上海市徐汇区宛平南路650号 

Applicant address:

650 Wanping Road South, Xuhui District, Shanghai, China 

Study leader's address:

650 Wanping Road South, Xuhui District, Shanghai, 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:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, 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:

2019-034 

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岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-25 

伦理委员会联系人:

殷从全 

Contact Name of the ethic committee:

Congquan Yin 

伦理委员会联系地址:

上海市虹口区甘河路110号 

Contact Address of the ethic committee:

110 Ganhe Road, Hongkou District, Shanghai, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021 65161782 

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岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, Shanghai, 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):

上海市

市(区县):

虹口区

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源:

国家重点基础研究发展计划(973计划) 

Source(s) of funding:

National Basic Research Program of China (973 Program) 

研究疾病:

肺癌相关性疲乏 

Target disease:

Lung Cancer related Fatigue 

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:

其它 

Study phase:

N/A 

研究目的:

采用多中心、双盲、随机对照的方法,利用BFI-C、QLQ-C30以及HAMD量表观察针刺对照假针刺干预肺癌手术后癌因性疲乏的效果,为针灸治疗癌因性疲乏的临床应用提供更高质量的证据。 

Objectives of Study:

A multi-center, double-blind, randomized controlled method was used to observe the effect of acupuncture on cancer-related fatigue by BFI-C, QLQ-C30 and HAMD scales. Exploring the high-quality evidence for the clinical application of acupuncture in the treatment of cancer-related fatigue. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 符合上述肺腺癌诊断标准; 2. 肺癌手术后3-6个月内,且未在化疗期间; 3. 卡氏评分表(KPS)评分大于等于80分者; 4. 符合CRF的西医诊断标准且简短疲劳量表(BFI-C)评分在4分及以上; 5. 年龄18~75岁,性别不限; 6. 同意参加本研究,理解并签署知情同意书。 

Inclusion criteria

1. It meets the diagnostic criteria of lung adenocarcinoma; 2. 3-6 months after lung cancer surgery, and not during chemotherapy; 3. Those whose KPS score is greater than or equal to 80; 4. According to the diagnostic criteria of CRF, the score of BFI-C was above 4; 5. Aged 18 to 75 years male and female; 6. Agree to participate in this study, understand and sign the informed consent. 

排除标准:

1. 合并其他癌症或较为严重的心、肝、肾等慢性疾病; 2. 患有精神疾患,或有严重的认知障碍,不能参与合作的患者; 3. 慢性疲劳综合症(CFS)等其他生理或病理性疲劳; 4. 在过去6个月内接受过针刺的患者; 5. 妊娠或哺乳期妇女。 

Exclusion criteria:

1. Complication with other cancers or more serious chronic diseases such as heart, liver and kidney; 2. Patients with mental disorders or severe cognitive impairment who are unable to participate in cooperation; 3. Chronic fatigue syndrome (CFS) and other physiological or pathological fatigue; 4. Patients who have received acupuncture in the past six months; 5. Pregnant or lactating women. 

研究实施时间:

Study execute time:

From2019-06-01To 2022-06-01 

干预措施:

Interventions:

组别:

干预组

样本量:

160

Group:

Experimental group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electro-Acupuncture

Intervention code:

组别:

对照组

样本量:

160

Group:

Control Group

Sample size:

干预措施:

假电针

干预措施代码:

Intervention:

Sham Acupuncture

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 

市(区县):

虹口区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

静安区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市胸科医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Chest Hospitial  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

徐汇区 

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 Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

简短疲乏量表

指标类型:

主要指标 

Outcome:

Brief Fatigue Inventory-Chinese Version

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量问卷评估

指标类型:

次要指标 

Outcome:

EORTC QLQ-C30

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Rating Scale for Depression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评估

指标类型:

次要指标 

Outcome:

Safety assessment

Type:

Secondary 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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

由独立的第三方统计人员进行区组化分层随机

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

Stratified block randomization conduct by independent statistists.

盲法:

受试者盲

Blinding:

Participant Blinding

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2022-12 ResMan

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

2022-12 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:

采用病历记录表记录数据,各中心人员在完成各评估后上传至EDC系统。

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

Data were recorded by CRFs, and the staff of each center uploaded to EDC system after completing the evaluation.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-27
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