艾灸治疗胃肠道肿瘤相关性疲乏的随机对照研究

注册号:

Registration number:

ITMCTR2200006572

最近更新日期:

Date of Last Refreshed on:

2022-09-08

注册时间:

Date of Registration:

2022-09-08

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

艾灸治疗胃肠道肿瘤相关性疲乏的随机对照研究

Public title:

Effects of Moxibustion on Gastrointestinal Cancer-Related Fatigue: A Randomized, Controlled Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

艾灸治疗胃肠道肿瘤相关性疲乏的随机对照研究

Scientific title:

Effects of Moxibustion on Gastrointestinal Cancer-Related Fatigue: A Randomized, Controlled 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:

ChiCTR2200063494 ; ChiMCTR2200006572

申请注册联系人:

范倩

研究负责人:

范倩

Applicant:

Qian Fan

Study leader:

Qian Fan

申请注册联系人电话:

Applicant telephone:

18217297588

研究负责人电话:

Study leader's telephone:

18217297588

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:

707503886@qq.com

研究负责人电子邮件:

Study leader's E-mail:

707503886@qq.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:

上海市徐汇区宛平南路725号

研究负责人通讯地址:

上海市徐汇区宛平南路725号

Applicant address:

No.725,South Wanping Road,Xuhui District,Shanghai

Study leader's address:

No.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:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022LCSY048

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:

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:

Medical Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese&

伦理委员会批准日期:

Date of approved by ethic committee:

2022/7/14 0:00:00

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:

No.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

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

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:

No.725,South Wanping Road,Xuhui District,Shanghai

经费或物资来源:

ZYZD001-017(区域医疗中心017)

Source(s) of funding:

ZYZD001-017(Regional Medical Center 017)

研究疾病:

胃肠道肿瘤相关性疲乏

研究疾病代码:

Target disease:

Gastrointestinal Cancer-Related Fatigue

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

采用随机、单盲、安慰灸对照的研究方法,将符合纳入标准的胃肠道肿瘤相关性疲乏患者随机分配到艾灸组与安慰灸对照组(假艾灸)两个组别,借助简易疲乏量表(BFI-C)、生活质量调查问卷(QLQ-C30)、广泛性焦虑障碍量表(GAD-7)、生物学指标(血常规,包括白细胞、血红蛋白、血小板及淋巴细胞;CD3+、CD4+、CD8+、CD4+/CD8+)为评价指标,评价艾灸治疗胃肠道肿瘤相关性疲乏的临床有效性与安全性,以期为艾灸治疗胃肠道肿瘤相关性疲乏提供科学依据。

Objectives of Study:

Through a randomized, single-blind, placebo-moxibustion-controlled study method, patients with gastrointestinal cancer-related fatigue who met the inclusion criteria were randomly assigned to two groups, the moxibustion group and the placebo moxibustion control group (sham moxibustion group).The evaluation indicators were Brief Fatigue Index (BFI-C), Quality of Life Questionnaire (QLQ-C30), Generalized Anxiety Disorder Scale (GAD-7), biological indicators (blood test, including white blood cells, hemoglobin, platelets and lymphocytes; CD3+, CD4+ , CD8+, CD4+/CD8+) to evaluate the clinical efficacy and safety of moxibustion in the treatment of gastrointestinal cancr-related fatigue, in order to provide a scientific basis for moxibustion in the treatment of gastrointestinal cancer-related fatigue.

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)符合上述胃癌和结直肠癌的诊断标准,TNM分期为Ⅱ~Ⅲ期;符合上述CRF的诊断标准,疲乏发生在胃癌和结直肠癌确诊之后,且与癌症本身或癌症相关治疗有关; 2)年龄18~70岁; 3)ECOG评分≤2分; 4)BFI-C≥4分; 5)预估生存期≥6个月; 6)患者在入组时的前3个月内或之前从未接受过针灸治疗; 7)无精神及智力异常,能理解各项量表条文并完成评定; 8)同意参加本研究并签署书面知情同意书。

Inclusion criteria

1) Meet the diagnostic criteria for gastric cancer and colorectal cancer, TNM staging is II to III; meet the diagnostic criteria for cancer-related fatigue(CRF), fatigue occurs after the diagnosis of gastric cancer and colorectal cancer, and is related to the cancer itself or cancer-related treatment; 2) Ages range from 18 to 70 years old; 3) ECOG score ≤ 2 points; 4) BFI-C≥4 points; 5) Estimated survival period ≥ 6 months; 6) The patient has never received acupuncture or moxibustion within the first 3 months of enrollment; 7) No mental or intellectual abnormality, able to understand the provisions of various scales and complete the assessment; 8) Agree to participate in this study and sign the written informed consent.

排除标准:

1)高度怀疑恶性肿瘤,但找不到原发癌灶者; 2)患有重大躯体疾病,如合并较为严重的心、肝、肾等重大疾病; 3)预期寿命小于6个月,或卧床不起者; 4)妊娠或哺乳期患者; 5)有症状的精神疾病及精神障碍者,因吸毒、嗜酒、滥用精神类药物等导致不能正常进行沟通的患者; 6)艾灸部位有溃疡、脓疮、皮肤感染等; 7)患者近1月内因疲乏曾接受艾灸治疗者。

Exclusion criteria:

1) Those who are highly suspected of malignant tumor but cannot find the primary tumor; 2) Suffering from major physical diseases, such as serious diseases of the heart, liver, kidney, etc.; 3) Life expectancy is less than 6 months, or bedridden; 4) Pregnant or lactating patients; 5) Symptomatic mental illness and mental disorders, patients who cannot communicate normally due to drug addiction, alcohol addiction, abuse of psychotropic substances, etc.; 6) There are ulcers, abscesses, skin infections, etc. at the moxibustion site; 7) Patients who have received moxibustion therapy due to fatigue in the past 1 month.

研究实施时间:

Study execute time:

From 2022-07-01

To      2022-06-30

征募观察对象时间:

Recruiting time:

From 2022-08-30

To      2025-06-30

干预措施:

Interventions:

组别:

对照组

样本量:

37

Group:

Control group

Sample size:

干预措施:

安慰灸

干预措施代码:

2

Intervention:

placebo-moxibustion

Intervention code:

组别:

治疗组

样本量:

37

Group:

Therapy group

Sample size:

干预措施:

艾灸

干预措施代码:

1

Intervention:

moxibustion

Intervention code:

样本总量 Total sample size : 74

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):

徐汇

Country:

China

Province:

Shanghai

City:

Xuhui District

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 first class

测量指标:

Outcomes:

指标中文名:

简易疲乏量表(BFI-C)

指标类型:

次要指标

Outcome:

Brief Fatigue Index (BFI-C)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

广泛性焦虑障碍量表(GAD-7)

指标类型:

次要指标

Outcome:

Generalized Anxiety Disorder Scale (GAD-7)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易疲乏量表(BFI-C)分数降低≥3分的人数百分比

指标类型:

主要指标

Outcome:

Percentage of patients with a reduction of ≥3 points on the Brief Fatigue Index (BFI-C) score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量核心量表(QLQ-C30)

指标类型:

次要指标

Outcome:

Quality of Life Questionnaire (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:

血常规

指标类型:

次要指标

Outcome:

Blood test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清T淋巴细胞亚群

指标类型:

次要指标

Outcome:

Serum T lymphocyte subsets

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:

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 70
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):

采用SAS 9.4统计分析软件的“Proc plan”程序产生研究所需的随机分配方案,并制成随机分配卡片,用信封密封,信封顺序与卡片序号相同。

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

The "Proc plan" program of the SAS 9.4 statistical analysis software was used to generate the random allocation plan required for the study, and a random allocation card was made, sealed with an envelope, and the order of the envelope was the same as the serial number of the card.

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):

不共享

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

do not share

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:

病例记录表(CRF)

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

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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