外用中药预防放射性皮肤损伤的临床研究

注册号:

Registration number:

ITMCTR2024000016

最近更新日期:

Date of Last Refreshed on:

2024-01-30

注册时间:

Date of Registration:

2024-01-30

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

外用中药预防放射性皮肤损伤的临床研究

Public title:

Effect of an herbal gel for the prevention of acute radiation dermatitis in patients with cancer: an open-label randomized clinical trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

外用中药预防放射性皮肤损伤的临床研究

Scientific title:

Effect of an herbal gel for the prevention of acute radiation dermatitis in patients with cancer: an open-label randomized clinical trial

研究课题的正式科学名称简写:

Scientific title acronym:

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:

金嘉悦

研究负责人:

刘杰

Applicant:

Jiayue Jin

Study leader:

Jie Liu

申请注册联系人电话:

Applicant telephone:

18946672334

研究负责人电话:

Study leader's telephone:

13718716339

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:

jinjiayue2009@163.com

研究负责人电子邮件:

Study leader's E-mail:

dr.liujie@163.com

申请单位网址(自愿提供):

Study leader's 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:

北京市西城区北线阁5号中国中医科学院广安门医院

研究负责人通讯地址:

北京市西城区北线阁5号中国中医科学院广安门医院

Applicant address:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing 100053, China

Study leader's address:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing 100053, 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:

中国中医科学院广安门医院

Applicant's institution:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2020-027-KY

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院广安门医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2020/8/4 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Jie Qiao

伦理委员会联系地址:

北京市西城区北线阁5号中国中医科学院广安门医院

Contact Address of the ethic committee:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing , China

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-88001552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市西城区北线阁5号中国中医科学院广安门医院

Primary sponsor's address:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing , 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号中国中医科学院广安门医院

Institution
hospital:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences

Address:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing , China

经费或物资来源:

北京市科技计划首都临床特色应用项目

Source(s) of funding:

Capital clinical characteristics applied research project of Beijing Municipal Science & Technology plan

研究疾病:

放射性皮肤损伤

研究疾病代码:

Target disease:

radiation dermatitis

Target disease code:

研究类型:

Study type:

预防性研究

Prevention

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

II期临床试验

Phase II clinical trial

研究目的:

评价外用中药预防放射性皮肤损伤的有效性和安全性

Objectives of Study:

This study investigated the effectiveness and safety of an herbal gel for the prevention of acute radiation dermatitis in patients with cancer.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.在任何研究相关程序开始前,患者对本研究已充分了解并自愿签署书面知情同意书; 2.年龄≥18岁,性别不限; 3.经病理学明确诊断的乳腺癌、肺癌和头颈部肿瘤等; 4.拟行不少于4周的外放射治疗。

Inclusion criteria

The eligible patients were aged ≥18 years with pathologically confirmed breast, lung, or head and neck cancer of any stage, and scheduled to receive RT for ≥4 weeks.

排除标准:

1. 拟放疗部位曾经接受过放射治疗或有严重未愈合的皮肤损伤; 2. ECOG 评分>2; 3. 有严重、未控制的器质性病变或感染; 4. 对本试验药物过敏者; 5. 严重的心理或精神异常、药物成瘾或酒精依赖者; 6. 妊娠或哺乳期女性。

Exclusion criteria:

The exclusion criteria were prior RT or serious lesions on the skin in the treatment area, poor Eastern Cooperative Oncology Group (ECOG) performance status score (>2), pregnancy or lactation, severe or uncontrolled systemic disease or infection, known allergy or hypersensitivity to gels, significant psychiatric disturbance, drug addiction, or alcohol dependence.

研究实施时间:

Study execute time:

From 2020-08-04

To      2022-04-30

征募观察对象时间:

Recruiting time:

From 2020-11-23

To      2021-11-28

干预措施:

Interventions:

组别:

治疗组

样本量:

36

Group:

interventional group

Sample size:

干预措施:

发生2级及以上放射性皮肤损伤后应用外用中药

干预措施代码:

Intervention:

gel treatment upon the development of grade 2 RID

Intervention code:

组别:

预防组

样本量:

36

Group:

prophylactic group

Sample size:

干预措施:

放疗前一天开始外用中药

干预措施代码:

Intervention:

gel treatment one day before RT

Intervention code:

样本总量 Total sample size : 72

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

单位级别:

三级甲等医院

Institution/hospital:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

Class III, Class A hospital

测量指标:

Outcomes:

指标中文名:

症状负担

指标类型:

次要指标

Outcome:

symptom burden

Type:

Secondary indicator

测量时间点:

放疗期间每周

测量方法:

Skindex-16

Measure time point of outcome:

weekly intervals during RT

Measure method:

Skindex-16

指标中文名:

不良事件

指标类型:

副作用指标

Outcome:

adverse events

Type:

Adverse events

测量时间点:

放疗期间每周

测量方法:

CTCAE4.0

Measure time point of outcome:

weekly intervals during RT

Measure method:

CTCAE4.0

指标中文名:

ECOG评分

指标类型:

次要指标

Outcome:

Eastern Cooperative Oncology Group performance status score

Type:

Secondary indicator

测量时间点:

放疗开始前、放疗结束时

测量方法:

ECOG

Measure time point of outcome:

before and at the end of RT

Measure method:

Eastern Cooperative Oncology Group performance status score

指标中文名:

急性放射性皮肤损伤

指标类型:

主要指标

Outcome:

acute radiation dermatitis

Type:

Primary indicator

测量时间点:

放疗期间每周

测量方法:

RTOG/EORTC

Measure time point of outcome:

weekly intervals during RT

Measure method:

RTOG/EORTC

指标中文名:

生活质量

指标类型:

次要指标

Outcome:

Health-related quality of life

Type:

Secondary indicator

测量时间点:

放疗开始前、放疗结束时

测量方法:

EORTC QLQ-C30

Measure time point of outcome:

before and at the end of RT

Measure method:

EORTC QLQ-C30

指标中文名:

NRS评分

指标类型:

次要指标

Outcome:

numerical rating scale

Type:

Secondary indicator

测量时间点:

放疗期间每周

测量方法:

NRS

Measure time point of outcome:

weekly intervals during RT

Measure method:

numerical rating scale

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

结束

Completed

年龄范围:

最小 32
Min age years
最大 86
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

与本试验数据管理、统计分析无关的生物统计学家借助SAS 9.2统计软件产生随机分配序列。

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

Randomization was performed by an independent biostatistician using a computer-generated list and allocation concealment.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

为了获得访问权限,数据请求者发送邮件至dr.liujie@163.com,并签署数据访问协议

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

Proposals should be directed to dr.liujie@163.com; to gain access, data requestors will need to sign a data access agreement.

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:

数据采集:病例记录表,真实世界数据管理平台 数据管理:真实世界数据管理平台

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

Data collection: CRF and Real world data management platform Data management: Real world data management platform

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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