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Clinical Research on the Intervention of Lei-Huo Moxibustion on Cancer-Related Fatigue in Patients with Qi Stagnation and Blood Stasis Type of Colorectal Cancer Undergoing Chemotherapy

注册号：

Registration number：

ITMCTR2025000305

最近更新日期：

Date of Last Refreshed on：

2025-02-17

注册时间：

Date of Registration：

2025-02-17

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

雷火灸干预气滞血瘀型结直肠癌化疗患者癌因性疲乏的临床研究

Public title：

Clinical Research on the Intervention of Lei-Huo Moxibustion on Cancer-Related Fatigue in Patients with Qi Stagnation and Blood Stasis Type of Colorectal Cancer Undergoing Chemotherapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

雷火灸干预气滞血瘀型结直肠癌化疗患者癌因性疲乏的临床研究

Scientific title：

Clinical Research on the Intervention of Lei-Huo Moxibustion on Cancer-Related Fatigue in Patients with Qi Stagnation and Blood Stasis Type of Colorectal Cancer Undergoing Chemotherapy

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：

杨晓冰

研究负责人：

洪艳燕

Applicant：

Yang Xiaobing

Study leader：

Hong Yanyan

申请注册联系人电话：

Applicant telephone：

13866774414

研究负责人电话：

Study leader's telephone：

18951755277

申请注册联系人传真 ：

Applicant Fax：

无

研究负责人传真：

Study leader's fax：

无

申请注册联系人电子邮件：

Applicant E-mail：

20231043@njucm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

fsyy00210@njucm.edu.cn

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：

江苏省南京市秦淮区大明路157号

研究负责人通讯地址：

江苏省南京市秦淮区大明路157号

Applicant address：

No. 157 Daming Road Qinhuai District Nanjing City Jiangsu Province

Study leader's address：

No. 157 Daming Road Qinhuai District Nanjing City Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

210022

研究负责人邮政编码：

Study leader's postcode：

210022

申请人所在单位：

南京中医药大学

Applicant's institution：

Nanjing University of 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：

KY2025016

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

南京市中医院伦理委员会

Name of the ethic committee：

Nanjing Hospital of Chinese Medicine Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/7 0:00:00

伦理委员会联系人：

刘峥

Contact Name of the ethic committee：

Liu Zheng

伦理委员会联系地址：

江苏省南京市大明路157号科研综合楼14楼1418办公室

Contact Address of the ethic committee：

Office 1418 14th Floor Scientific Research Complex No. 157 Daming Road Nanjing Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

025-52276505

伦理委员会联系人邮箱：

Contact email of the ethic committee：

njszyyll@163.com

研究实施负责（组长）单位：

南京市中医院

Primary sponsor：

Nanjing Hospital of Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市大明路157号

Primary sponsor's address：

No. 157 Daming Road Nanjing Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南京市

Country：

china

Province：

Jiangsu

City：

Nanjing

单位(医院)：

南京市中医院

具体地址：

江苏省南京市大明路157号

Institution
hospital：

Nanjing Hospital of Chinese Medicine

Address：

No. 157 Daming Road Nanjing Jiangsu Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

结直肠癌

研究疾病代码：

2E61.0和2E61.1

Target disease：

Colorectal cancer

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：

其它

Others

研究目的：

①观察雷火灸疗法对气滞血瘀型结直肠癌化疗患者癌因性疲乏的临床疗效，以及对生活质量、睡眠质量的改善程度。 ②探讨雷火灸干预对气滞血瘀型结直肠癌化疗患者癌因性疲乏的潜在作用机制，为中医护理在肿瘤康复领域的应用提供科学依据。 ③评估雷火灸干预的安全性和接受度，为将来在临床实践中推广雷火灸治疗癌因性疲乏提供参考。

Objectives of Study：

(1) To observe the clinical efficacy of thunder fire moxibustion therapy on cancer-induced fatigue in patients with colorectal cancer with qi stagnation and blood stasis as well as the improvement of quality of life and sleep quality. (2) To explore the potential mechanism of Lei Huo moxibustion intervention on cancer-induced fatigue in patients with colorectal cancer with qi stagnation and blood stasis so as to provide a scientific basis for the application of traditional Chinese medicine nursing in the field of cancer rehabilitation. (3) To evaluate the safety and acceptance of thunder fire moxibustion intervention so as to provide a reference for the promotion of thunder fire moxibustion in the treatment of cancer-related fatigue in clinical practice in the future.

药物成份或治疗方案详述：

治疗方案 （1）对照组 参照南京市中医院肿瘤科结直肠肿瘤化疗护理方案，常规进行保肝、止吐、护胃、营养支持、止痛、通便及止泻等治疗；对患者及家属进行健康教育，对患者进行病情观察、辨证施护、心理护理、康复指导等。 （2）试验组 在对照组基础上，给予雷火灸干预，具体方法如下。 ①选取穴位： 主穴：中脘、神阙、天枢、气海、关元； 配穴：足三里、合谷。 ②操作方法： 使用赵氏雷火灸传统医药研究所提供的专门雷火灸条和竹质灸盒。从化疗第 1 日开始干预，雷火灸 1 次/天， 5min/穴位，30min/次。 ③干预疗程： 5 天为一个疗程（与化疗周期保持一致），共干预两个疗程。两个疗程之间的间隔期为 7-8 天。

Description for medicine or protocol of treatment in detail：

Treatment options (1) Control group According to the chemotherapy nursing plan for colorectal tumors in the Department of Oncology of Nanjing Hospital of Traditional Chinese Medicine hepatoprotection antiemetic gastric protection nutritional support analgesic laxative and antidiarrheal treatments were routinely carried out. Carry out health education for patients and their families and carry out disease observation syndrome differentiation care psychological care rehabilitation guidance etc. (2) Experimental group On the basis of the control group thunder fire moxibustion intervention was given and the specific methods were as follows. (1) Select acupuncture points: Main acupoints: Zhongguan Shenque Tianshu Qihai Guan Yuan; Acupoints: Zusanli Hegu. (2) How to operate: Use the special thunder fire moxibustion strips and bamboo moxibustion boxes provided by the Zhao's Lei Huo Moxibustion Traditional Medicine Research Institute. Intervention began on the 1st day of chemotherapy thunder fire moxibustion 1 time/day 5min/acupuncture point 30min/time. (3) Intervention course: A 5-day course (consistent with the chemotherapy cycle) was administered for a total of two courses. The interval between the two sessions is 7-8 days.

纳入标准：

①符合气滞血瘀型结直肠癌化疗患者伴癌因性疲乏的诊断标准； ②首次接受化疗方案且有 2 个及以上化疗周期治疗计划的患者； ③Piper 疲乏修订量表评分＞3 分，即中、重度疲乏； ④年龄≥18 周岁； ⑤意识清楚，能准确表达灸感； ⑥自愿参加且签署知情同意书。 同时符合上述标准则予以纳入本试验。

Inclusion criteria

(1) Meet the diagnostic criteria for chemotherapy patients with colorectal cancer with qi stagnation and blood stasis with cancer-induced fatigue; (2) Patients who are receiving chemotherapy regimens for the first time and have 2 or more chemotherapy cycle treatment plans; (3) Piper Fatigue Revised Scale score > 3 points i.e. moderate and severe fatigue; (4) Age≥ 18 years old; (5) Clear consciousness and ability to accurately express moxibustion feelings; (6) Voluntary participation and signed informed consent. If the above criteria are met at the same time they will be included in this test.

排除标准：

①合并心、肝、肾、内分泌系统等严重疾病患者； ②局部皮肤破溃不适合雷火灸及对雷火灸过敏者； ③有精神疾病和认知障碍，语言表达不清的患者； ④妊娠或哺乳期的患者； ⑤同时参与其他临床试验的患者； ⑥依从性差、无法合作的患者。 符合上述任意一项则不能纳入本试验。

Exclusion criteria：

(1) Patients with serious diseases such as heart liver kidney and endocrine system; (2) Local skin ulceration is not suitable for thunder fire moxibustion and those who are allergic to thunder fire moxibustion; (3) Patients with mental illness and cognitive impairment and unclear language expression; (4) pregnant or lactating patients; (5) Patients who participate in other clinical trials at the same time; (6) Patients with poor compliance and inability to cooperate. Any of the above conditions cannot be included in this trial.

研究实施时间：

Study execute time：

从From 2025-03-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-03-01

至To      2025-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

40

Group：

Experimental group

Sample size：

干预措施：

雷火灸

干预措施代码：

D009071

Intervention：

Thunder fire moxibustion

Intervention code：

组别：

对照组

样本量：

40

Group：

Control group

Sample size：

干预措施：

癌因性疲乏常规护理

干预措施代码：

Intervention：

Routine care for cancer-related fatigue

Intervention code：

样本总量 Total sample size ： 80

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南京市

Country：

china

Province：

Jiangsu

City：

Nanjing

单位(医院)：

南京市中医院

单位级别：

市级三甲医院

Institution/hospital：

Nanjing Hospital of Chinese Medicine

Level of the institution：

Municipal tertiary hospital

测量指标：

Outcomes：

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

TCM Syndrome Points

Type：

Secondary indicator

测量时间点：

入组前、第二疗程后

测量方法：

选用尼莫地平法进行评定

Measure time point of outcome：

Before enrollment after the second course of treatment

Measure method：

The nimodipine method was used for evaluation

指标中文名：

生化指标（血常规）

指标类型：

次要指标

Outcome：

Biochemical indexes (blood count)

Type：

Secondary indicator

测量时间点：

入组前、第二疗程后

测量方法：

采集患者血液标本

Measure time point of outcome：

Before enrollment after the second course of treatment

Measure method：

A blood sample is collected from the patient

指标中文名：

疲乏程度

指标类型：

主要指标

Outcome：

Degree of fatigue

Type：

Primary indicator

测量时间点：

入组前、第一疗程后、第二疗程前、第二疗程后、随访期（四周）

测量方法：

采用 Piper 疲乏修订量表评估

Measure time point of outcome：

Before enrollment, after the first course of treatment, before the second course of treatment, after the second course of treatment, follow-up period (four weeks)

Measure method：

Assessed using the Piper Fatigue Revised Scale

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

入组前、第二疗程后、随访期（四周）

测量方法：

采用癌症患者生命质量测定量表评估

Measure time point of outcome：

Before enrollment, after the second course of treatment, follow-up period (four weeks)

Measure method：

Assessed using the Cancer Patient Quality of Life Measurement Scale

指标中文名：

睡眠质量

指标类型：

次要指标

Outcome：

Sleep quality

Type：

Secondary indicator

测量时间点：

入组前、第二疗程后、随访期（四周）

测量方法：

采用匹兹堡睡眠质量指数量表评估

Measure time point of outcome：

Before enrollment, after the second course of treatment, follow-up period (four weeks)

Measure method：

Assessed using the Pittsburgh Sleep Quality Index scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

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 岁
Min age years
最大 90 岁
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）：

将符合诊断纳入排除标准的患者按 1：1 的比例原则分为 2 组，分别为对照组 40 例、试验组 40 例，共 80 例。方法采用计算机软件将 80 个编号随机生成随机号码及随机分组，并且填写随机分配卡，包括序号、随机号码及组别，并将其装入不透明的密封信封内，并且密封，然后在信封外面编写序号。根据病人进入临床治疗的先后顺序将对应的信封拆开，严格按照卡片上填写的分组分别为患者采取相对应治疗方法进行治疗。遵循分配隐藏原则，由专人进行随机管理和操作，随机操作人员不参与疗效评价、雷火灸干预和统计分析。

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

The patients who met the exclusion criteria for diagnosis were divided into 2 groups according to the principle of 1:1 ratio which were 40 cases in the control group and 40 cases in the experimental group a total of 80 cases. Method: 80 numbers were randomly generated and randomly grouped by computer software and the random assignment card was filled in including serial number random number and group and it was packed into an opaque sealed envelope sealed and then the serial number was written on the outside of the envelope. According to the order in which the patients enter the clinical treatment the corresponding envelopes are opened and the corresponding treatment methods are taken for the patients in strict accordance with the grouping filled in on the card. Following the principle of allocation concealment random management and operation are carried out by special personnel and random operators do not participate in efficacy evaluation thunder fire moxibustion intervention and statistical analysis.

盲法：

由于雷火灸操作的特殊性，本研究无法对雷火灸操作者和受试者实施盲法，故只对资料收集者和统计分析者实施盲法。 对资料收集者实施盲法：具体表现为资料收集者不清楚患者的具体分组情况，根据量表或问卷对患者询问，不能同受试者交流与资料收集无关的内容。 对统计分析者实施盲法：具体表现为研究者对患者姓名、编号和分组等信息进行隐藏，将由不参与本研究的第三方人员进行统计分析。

Blinding：

Due to the particularity of the operation of thunder fire moxibustion it was not possible to blind the operators and subjects of thunder fire moxibustion in this study so only the data collectors and statistical analysts were blinded. Blinding of data collectors: the data collectors are not aware of the specific grouping of patients ask patients according to scales or questionnaires and cannot communicate with subjects about content unrelated to data collection. Blinding of statistical analysts: Specifically the investigator hides the information such as patient name number and grouping and statistical analysis will be performed by third-party personnel who do not participate in this study.

是否共享原始数据：

IPD sharing：

否

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）：

不共享原始数据

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

Raw data is not shared

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：

一部分为病例报告，一部分为电子集采系统

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

Part of it is a case report and part of it is an electronic centralized procurement system

数据管理委员会：

Data Managemen Committee：

无

No

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）：

毕业论文

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

Dissertation

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