ChiCTR2600121765 版本V1.1 版本创建时间2026/04/02 16:10:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600121765 

最近更新日期：

Date of Last Refreshed on：

 2026-04-02 16:07:43 

注册时间：

Date of Registration：

 2026-04-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中药贴敷脾胃经穴位预防化疗相关性恶心呕吐、腹泻及便秘的效果观察

Public title：

Observation on the Efficacy of Chinese Herbal Application at Acupoints of the Spleen and Stomach Meridians in Preventing Chemotherapy-Induced Nausea, Vomiting, Diarrhea and Constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中药贴敷脾胃经穴位预防化疗相关性恶心呕吐、腹泻及便秘的效果观察

Scientific title：

Observation on the Efficacy of Chinese Herbal Application at Acupoints of the Spleen and Stomach Meridians in Preventing Chemotherapy-Induced Nausea, Vomiting, Diarrhea and Constipation

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：

高梦美 

研究负责人：

郑超 

Applicant：

Gao Mengmei 

Study leader：

Zheng Chao 

申请注册联系人电话：

Applicant telephone：

 +86 195 1018 4683

研究负责人电话：

Study leader's
telephone：

+86 188 6687 0131

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：

 wy2580muyang@163.com

研究负责人电子邮件：

Study leader's E-mail：

 chaozheng@sdu.edu.cn

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：

中国山东省济南市天桥区北园大街247号

研究负责人通讯地址：

中国山东省济南市天桥区北园大街247号

Applicant address：

247 Beiyuan St, Tianqiao District, Jinan, Shandong, China

Study leader's address：

247 Beiyuan St, Tianqiao District, Jinan, Shandong, 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：

山东大学齐鲁第二医院

Applicant's institution：

The Second Qilu Hospital of Shandong University

研究负责人所在单位：

山东大学齐鲁第二医院

Affiliation of the Leader：

The Second Qilu Hospital of Shandong University

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：

 KYLL2026033581

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：

山东大学齐鲁第二医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee, The Second Qilu Hospital of Shandong University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-11 00:00:00

伦理委员会联系人：

吕军

Contact Name of the ethic committee：

Lü Jun

伦理委员会联系地址：

中国山东省济南市天桥区北园大街247号

Contact Address of the ethic committee：

247 Beiyuan St, Tianqiao District, Jinan, Shandong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 8587 5139

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：

山东大学齐鲁第二医院

Primary sponsor：

The Second Qilu Hospital of Shandong University

研究实施负责（组长）单位地址：

中国山东省济南市天桥区北园大街247号

Primary sponsor's address：

247 Beiyuan St, Tianqiao District, Jinan, Shandong, 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)：

山东

市(区县)：

济南

Country：

China

Province：

ShanDong

City：

Jinan

单位(医院)：

山东大学齐鲁第二医院

具体地址：

中国山东省济南市天桥区北园大街247号

Institution
hospital：

The Second Qilu Hospital of Shandong University

Address：

247 Beiyuan St, Tianqiao District, Jinan, Shandong, China

经费或物资来源：

自筹资金

Source(s) of funding：

Self-funded

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：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要目的：探讨中药贴敷脾胃经穴位对化疗相关性恶心呕吐、腹泻及便秘的有效性与安全性，以化疗后恶心呕吐、腹泻及便秘的程度为终点，证实神阙、天枢、中脘、下脘四穴的协同作用可改善化疗后的胃肠道不良反应。 次要目的：1. 优化化疗辅助治疗方案；2. 降低化疗后恶心呕吐及腹泻便秘等不良反应发生率；3. 提升患者化疗后恢复质量及就医满意度。  

Objectives of Study：

Chemotherapy, as one of the core modalities in the comprehensive treatment of malignant breast tumors, prolongs patients' survival and improves their prognosis; however, the chemotherapy-induced gastrointestinal adverse reactions it elicits—chemotherapy-induced nausea and vomiting (CINV), chemotherapy-induced diarrhea (CID), and chemotherapy-induced constipation (CIC)—have emerged as a critical bottleneck impairing patients' treatment compliance and quality of life. According to clinical data, the incidence of CINV is as high as 70%–80% among chemotherapy patients without preventive interventions, while those of CID and CIC can exceed 40% and 60%, respectively. Among patients receiving triple combination therapy for preventive intervention, the incidence of CINV reaches 55% within 24 hours after chemotherapy and surges to 78% within 120 hours. Even with the current intensified therapeutic regimen for chemotherapy-induced nausea and vomiting—specifically, the addition of olanzapine to the triple combination therapy—the incidence of CINV still remains at 63% within 120 hours after chemotherapy, with only 37% of patients achieving complete freedom from nausea and vomiting; in the meantime, the incidences of CID and CIC can still exceed 30% and 40%, respectively. These three conditions not only occur in isolation but also frequently present as combined symptoms such as vomiting-diarrhea and constipation-abdominal distension, thus forming a vicious cycle. Based on the traditional Chinese medicine (TCM) theories of treating internal diseases through external approaches and meridian conduction, Chinese herbal application enables medicinal ingredients to penetrate and be absorbed through the skin and acupoints. This approach avoids the additional gastrointestinal irritation caused by oral medications, and integrates the advantages of safety, convenience and practicability, which is well compatible with the physiological characteristic of compromised gastrointestinal function in chemotherapy patients. However, existing studies on Chinese herbal application for preventing post-chemotherapy gastrointestinal reactions have mostly focused on a single symptom or a small number of acupoints, lacking comprehensive coverage of symptoms including nausea and vomiting, diarrhea and constipation. Furthermore, evidence-based research on the synergistic effects of the four acupoints (Shenque, Tianshu, Zhongwan and Xiawan) remains inadequate. Therefore, this study takes these four acupoints as the research targets to conduct a clinical investigation on Chinese herbal application for post-chemotherapy gastrointestinal symptoms, aiming to clarify its efficacy and safety, and to provide a scientific basis for optimizing adjuvant chemotherapy regimens, enhancing patients' treatment tolerance and improving their quality of life.

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. 经组织学诊断为原发性浸润性乳腺癌的个体。 2. 年龄在 18 岁及以上、计划接受中/高致吐性化疗（HEC）的女性患者，包括不限于早期或晚期未接受过化疗的患者，或在晚期一线化疗开始前三个月以上接受过新辅助或辅助化疗的患者，且东部肿瘤协作组（ECOG）体力状态评分为 0-2 分。 3. 所使用的中/高致吐性化疗方案包括不限于蒽环类药物联合环磷酰胺为基础的化疗，或卡铂（AUC>=4）/ 顺铂为基础的化疗。

Inclusion criteria

1. Individuals with a histologically confirmed diagnosis of primary invasive breast cancer. 2. Female patients aged 18 years and above, scheduled to receive moderate/highly emetogenic chemotherapy (HEC), including but not limited to treatment-na?ve patients with early or advanced breast cancer, or patients who had received neoadjuvant or adjuvant chemotherapy more than three months prior to the initiation of first-line chemotherapy for advanced disease, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 3. The administered moderate/highly emetogenic chemotherapy regimens include but not limited to those based on anthracycline in combination with cyclophosphamide, or those based on carboplatin (AUC >= 4) or cisplatin.

排除标准：

1. 第 1 天计划接受低致吐性化疗（非 HEC）的患者，以及在接受高致吐性化疗前 4 周内因其他疾病接受过中药敷贴治疗的患者。 2. 因肠道疾病或恶性肿瘤引起的恶心呕吐、腹泻、便秘； 3. 所选穴位对应的皮肤存在病变、感染； 4. 对穴位贴敷的中药粉过敏。

Exclusion criteria：

1. Patients scheduled to receive low emetogenic chemotherapy (non-HEC) on Day 1, and those who had received Chinese herbal application therapy for other diseases within 4 weeks prior to the administration of highly emetogenic chemotherapy. 2. Nausea, vomiting, diarrhea or constipation caused by intestinal diseases or malignant tumors; 3. Skin lesions or infections at the selected acupoints; 4. Hypersensitivity to the Chinese herbal powder for acupoint application.

研究实施时间：

Study execute time：

从 From 2026-04-02 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-02 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

试验组Ⅰ

样本量：

 122

Group：

Trial Group Ⅰ

Sample size：

干预措施：

接受中药贴敷干预，敷贴穴位为天枢穴、神阙穴，敷贴时机为化疗前2-4小时，每日1次、每次贴敷8-12小时

干预措施代码：

Intervention：

The patients received Chinese herbal application intervention at Tianshu (ST25) and Shenque (CV8) acupoints. The application time of the topical plasters is 2–4 hours before chemotherapy, once daily, with each session lasting 8 to 12 hours.

Intervention code：

组别：

试验组Ⅱ

样本量：

 122

Group：

Trial Group Ⅱ

Sample size：

干预措施：

接受中药贴敷干预，敷贴穴位为天枢穴、神阙穴、中脘穴、下脘穴，敷贴时机为化疗前2-4小时，每日1次、每次贴敷8-12小时

干预措施代码：

Intervention：

The patients received Chinese herbal application intervention at Tianshu (ST25), Shenque (CV8), Zhongwan (CV12) and Xiawan (CV10) acupoints. The application time of the topical plasters is 2–4 hours before chemotherapy, once daily, with each session lasting 8 to 12 hours.

Intervention code：

组别：

对照组

样本量：

 122

Group：

Control Group

Sample size：

干预措施：

使用安慰剂贴敷，使用外观、气味、重量与中药贴相同，但不含有效药物成分的贴剂，贴于天枢、神阙、中脘、下脘穴

干预措施代码：

Intervention：

Placebo plasters, matching the TCM plasters in appearance, smell and weight without active ingredients, were externally applied at acupoints Tianshu (ST25), Shenque (CV8), Zhongwan (CV12) and Xiawan (CV10).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 济南 

Country：

China

Province：

ShanDong

City：

Jinan

单位(医院)：

 山东大学齐鲁第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Qilu Hospital of Shandong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

化疗后恶心程度

指标类型：

主要指标

Outcome：

Nausea severity after chemotherapy

Type：

Primary indicator

测量时间点：

化疗后 24 小时内、48 小时内及 120 小时内

测量方法：

视觉模拟评分法（VAS）

Measure time point of outcome：

Within 24 hours, within 48 hours, and within 120 hours after chemotherapy

Measure method：

Visual Analog Scale (VAS)

指标中文名：

化疗后呕吐情况

指标类型：

主要指标

Outcome：

Vomiting incidence after chemotherapy

Type：

Primary indicator

测量时间点：

化疗后 24 小时内、48 小时内及 120 小时内

测量方法：

WHO 抗肿瘤药物不良反应分级标准

Measure time point of outcome：

Within 24 hours, within 48 hours, and within 120 hours after chemotherapy

Measure method：

World Health Organization (WHO) Grading Criteria for Adverse Reactions to Antineoplastic Drugs

指标中文名：

化疗后便秘情况

指标类型：

主要指标

Outcome：

Constipation incidence after chemotherapy

Type：

Primary indicator

测量时间点：

化疗后 24 小时内、48 小时内及 120 小时内

测量方法：

CTCAE 便秘分级及便秘症状自评问卷（PAC-SYM）

Measure time point of outcome：

Within 24 hours, within 48 hours, and within 120 hours after chemotherapy

Measure method：

Common Terminology Criteria for Adverse Events (CTCAE) constipation grading and Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire

指标中文名：

化疗后腹泻情况

指标类型：

主要指标

Outcome：

Diarrhea incidence after chemotherapy

Type：

Primary indicator

测量时间点：

化疗后 24 小时内、48 小时内及 120 小时内

测量方法：

CTCAE 腹泻分级

Measure time point of outcome：

Within 24 hours, within 48 hours, and within 120 hours after chemotherapy

Measure method：

Common Terminology Criteria for Adverse Events (CTCAE) diarrhea grading

指标中文名：

安全性指标（包括：贴敷部位局部皮肤不良反应、血液学指标、生化指标）

指标类型：

副作用指标

Outcome：

Safety outcomes including local skin adverse reactions at the application site, hematologic parameters, and biochemical markers

Type：

Adverse events

测量时间点：

化疗后 24 小时内、48 小时内及 120 小时内

测量方法：

Measure time point of outcome：

Within 24 hours, within 48 hours, and within 120 hours after chemotherapy

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age NA 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

公开原始数据日期：2027 年 6 月 30 日；共享方式：通过临床试验公共管理平台 ResMan（网址：http://www.medresman.org）共享原始数据，公众可在该平台浏览数据，如需下载数据可联系研究者。

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

Date of Public Release of Raw Data: June 30, 2027; Method of Raw Data Sharing: Raw data will be shared via the Clinical Trial Public Management Platform ResMan (Website: http://www.medresman.org). The public can browse the data on this platform, and those in need of downloading the data may contact the researchers.

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

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-02 16:07:30