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Research on the Effect of Chu Needle Combined with Aromatherapy on Nausea Caused by Platinum-based Chemotherapy Drugs

注册号：

Registration number：

ITMCTR2025000470

最近更新日期：

Date of Last Refreshed on：

2025-03-05

注册时间：

Date of Registration：

2025-03-05

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

杵针联合芳香疗法对铂类化疗药物所致恶心的效果研究

Public title：

Research on the Effect of Chu Needle Combined with Aromatherapy on Nausea Caused by Platinum-based Chemotherapy Drugs

注册题目简写：

English Acronym：

研究课题的正式科学名称：

杵针联合芳香疗法对铂类化疗药物所致恶心的效果研究

Scientific title：

Research on the Effect of Chu Needle Combined with Aromatherapy on Nausea Caused by Platinum-based Chemotherapy Drugs

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：

邹伟

研究负责人：

邹伟

Applicant：

zouwei

Study leader：

zouwei

申请注册联系人电话：

Applicant telephone：

13699001973

研究负责人电话：

Study leader's telephone：

13699001973

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：

459681553@qq.com

研究负责人电子邮件：

Study leader's E-mail：

459681553@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：

中国四川省成都市人民南路三段十八号

研究负责人通讯地址：

中国四川省成都市人民南路三段十八号

Applicant address：

No. 18 Third Section Renmin South Road Chengdu City Sichuan Province China

Study leader's address：

No. 18 Third Section Renmin South Road Chengdu City Sichuan Province 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：

四川大学华西公共卫生学院（华西第四医院）

Applicant's institution：

West China School of Public Health (The Fourth Hospital of West China) Sichuan University

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：

HXSY-EC-KS2024098

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：

四川大学华西第四医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Fourth Hospital of West China, Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/25 0:00:00

伦理委员会联系人：

陈嘉熠

Contact Name of the ethic committee：

Chen Jiayi

伦理委员会联系地址：

中国四川省成都市人民南路三段十八号

Contact Address of the ethic committee：

No. 18 Third Section Renmin South Road Chengdu City Sichuan Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

028-85501599

伦理委员会联系人邮箱：

Contact email of the ethic committee：

huaxisiyuanlunli@163.com

研究实施负责（组长）单位：

四川大学华西公共卫生学院（华西第四医院）

Primary sponsor：

West China School of Public Health (The Fourth Hospital of West China) Sichuan University

研究实施负责（组长）单位地址：

中国四川省成都市人民南路三段十八号

Primary sponsor's address：

No. 18 Third Section Renmin South Road Chengdu City Sichuan Province 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu City

单位(医院)：

四川大学华西公共卫生学院（华西第四医院）

具体地址：

中国四川省成都市人民南路三段十八号

Institution
hospital：

West China School of Public Health (The Fourth Hospital of West China) Sichuan University

Address：

No. 18 Third Section Renmin South Road Chengdu City Sichuan Province China

经费或物资来源：

四川大学华西公共卫生学院（华西第四医院）

Source(s) of funding：

West China School of Public Health (The Fourth Hospital of West China) Sichuan University

研究疾病：

恶心呕吐

研究疾病代码：

Target disease：

nausea and vomiting

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：

通过杵针结合芳香疗法干预方式，降低含铂类化疗所致恶心发生率，为中医适宜技术在化疗毒性反应中的应用与推广提供临床依据和参考。

Objectives of Study：

Through the intervention of Chu Needle combined with aromatherapy reduce the incidence of nausea caused by platinum - containing chemotherapy and provide clinical evidence and reference for the application and promotion of appropriate traditional Chinese medicine techniques in the toxic reactions of chemotherapy.

药物成份或治疗方案详述：

1.研究设计：先通过随机数字表选样本量个数字并排序，再按除以 4 的余数分组，比例 1:1:1:1。然后编制含序号、组别等的分配卡，装进相同编号信封密封，专人保管，受试者依序入组 2.研究方法：本研究采用单中心、实效性RCT研究设计，将研究对象采用随机数字表法分为四个组进行研究。 3.研究步骤：本研究采用单中心、实效性RCT设计，将四川某三甲医院肿瘤科2025年4月-2026年9月含铂类化疗药患者分四组。确定样本量每组31例，考虑10%失访共需136例，用随机数字表分组。 干预方案：A0组按指南予止呕等基础治疗及健康宣教；A1组在此基础上加杵针干预，明确选穴与手法；A2组加芳香疗法，介绍精油配制与手法；A3组采用杵针联合芳香疗法。 评价指标涵盖一般资料、主要结局（用R-INVR量表）、次要结局（食欲、睡眠等相关指标），明确各指标评价节点。 统计分析方面，双人整理数据，用SPSS 26.0软件，按相应统计方法处理，以P＜0.05判断有无统计学差异。

Description for medicine or protocol of treatment in detail：

1. Research Design: First select a number of digits equal to the sample size from the random number table and sort them. Then group them according to the remainder when divided by 4 with a ratio of 1:1:1:1. Next prepare allocation cards containing information such as serial numbers and groups put them into envelopes with the same numbers for sealing and assign a dedicated person to take care of them. Subjects will be enrolled in sequence. 2. Research Method: This study adopts a single - center pragmatic RCT (Randomized Controlled Trial) research design. The research subjects will be divided into four groups using the random number table method for the study. 3. Research Steps: This study uses a single - center pragmatic RCT design. Patients undergoing platinum - containing chemotherapy in the Oncology Department of a tertiary - level first - class hospital in Sichuan Province from April 2025 to September 2026 will be divided into four groups. The sample size is determined to be 31 cases per group. Considering a 10% dropout rate a total of 136 cases are required. The random number table will be used for grouping. Intervention Plan: Group A0 will receive basic treatments such as anti - vomiting and health education according to the guidelines. Group A1 will receive Chu Needle intervention in addition to the above with clear acupoint selection and manipulation methods. Group A2 will receive aromatherapy with the introduction of essential oil preparation and manipulation methods. Group A3 will adopt the combination of Chu Needle and aromatherapy. Evaluation indicators cover general information primary outcomes (using the R - INVR scale) and secondary outcomes (related indicators such as appetite and sleep). The evaluation time points for each indicator are clearly defined. Regarding statistical analysis two researchers will organize the data. The SPSS 26.0 software will be used to process the data according to the corresponding statistical methods. A P - value less than 0.05 will be used to determine whether there is a statistically significant difference.

纳入标准：

1. 入选标准：①住院化疗患者，自愿签署知情同意并配合本研究；②经病理学确诊、符合诊断标准的恶性肿瘤，计划采用含铂类化疗药物至少2个周期的患者；③18岁≤年龄≤80岁；④KPS评分≥60分，预期生存期＞3个月。

Inclusion criteria

1. Inclusion criteria: ① Inpatients undergoing chemotherapy who voluntarily sign the informed consent form and are willing to cooperate with this study. ② Patients with malignant tumors that have been pathologically confirmed and meet the diagnostic criteria and who are planned to receive platinum - containing chemotherapy drugs for at least 2 cycles. ③ Age is between 18 and 80 years old (inclusive). ④ Karnofsky Performance Status (KPS) score is ≥ 60 points and the expected survival period is > 3 months.

排除标准：

2. 排除标准：①有精神疾或认知功能障碍患者；②合并有心、肝、肾等严重疾病及其功能严重障碍者；③非化疗因素引起的厌食症患者。

Exclusion criteria：

2. Exclusion criteria: ① Patients with mental disorders or cognitive impairment. ② Patients with severe diseases of the heart liver kidneys etc. and those with severe dysfunction of these organs. ③ Patients with anorexia not caused by chemotherapy factors.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-04-01

至To      2025-09-30

干预措施：

Interventions：

组别：

A2

样本量：

34

Group：

Group A2

Sample size：

干预措施：

芳香疗法干预

干预措施代码：

Intervention：

Aromatherapy Intervention

Intervention code：

组别：

A3

样本量：

34

Group：

Group A3

Sample size：

干预措施：

杵针联合芳香疗法干预

干预措施代码：

Intervention：

Intervention of Chu Needle Combined with Aromatherapy

Intervention code：

组别：

A1组

样本量：

34

Group：

Group A1

Sample size：

干预措施：

杵针干预

干预措施代码：

Intervention：

Intervention of Chu Needle

Intervention code：

组别：

A0

样本量：

34

Group：

Group A0

Sample size：

干预措施：

情志护理

干预措施代码：

Intervention：

Emotional Nursing Care

Intervention code：

样本总量 Total sample size ： 136

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu City

单位(医院)：

四川大学华西公共卫生学院（华西第四医院）

单位级别：

三级甲等

Institution/hospital：

West China School of Public Health (The Fourth Hospital of West China) Sichuan University

Level of the institution：

Tertiary - level first - class

测量指标：

Outcomes：

指标中文名：

化疗后恶心的发生率

指标类型：

主要指标

Outcome：

The incidence of nausea after chemotherapy

Type：

Primary indicator

测量时间点：

在化疗后24小时、化疗后第3、4、5天进行CIN评分

测量方法：

恶心呕吐以及干呕的量表

Measure time point of outcome：

The CIN score is carried out 24 hours after chemotherapy and on the 3rd, 4th, and 5th days after chemotherapy.

Measure method：

Scale/Questionnaire for Nausea, Vomiting and Retching

指标中文名：

食欲症状

指标类型：

次要指标

Outcome：

appetite symptoms

Type：

Secondary indicator

测量时间点：

在化疗后24小时、化疗后第3、4、5天进行CIN评分

测量方法：

食欲量化评价指标-NRS评分法

Measure time point of outcome：

The CIN score is carried out 24 hours after chemotherapy and on the 3rd 4th and 5th days after chemotherapy.

Measure method：

Quantitative Evaluation Index of Appetite (NRS Scoring Method)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

no

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

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 80 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）：

先通过随机数字表选样本量个数字并排序，再按除以 4 的余数分组，比例 1:1:1:1。然后编制含序号、组别等的分配卡，装进相同编号信封密封，专人保管，受试者依序入组。

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

First select a number of digits equal to the sample size from the random number table and sort them. Then group them according to the remainder when divided by 4 with a ratio of 1:1:1:1. Next prepare allocation cards containing information such as serial numbers and groups put them into envelopes with the same numbers for sealing and assign a dedicated person to take care of them. Subjects will be enrolled in sequence.

盲法：

Blinding：

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）：

无

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

no

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：

临床研究将根据风险大小制定相应的数据安全监察计划。所有不良事件均详细记录，恰当处理并追踪直到妥善解决或病情稳定，按照规定及时向伦理委员会、主管部门、申办者和药品监督管理部门报告严重不良事件与非预期事件等；主要研究者定期对所有不良事件进行累积性回顾，必要时召开研究者会议评估研究的风险与受益；双盲试验必要时可以进行紧急揭盲，以确保受试者安全与权益。

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

In the clinical study a corresponding data safety monitoring plan will be formulated based on the level of risk. All adverse events will be recorded in detail properly handled and followed up until they are resolved appropriately or the condition stabilizes. Serious adverse events and unexpected events will be reported to the ethics committee the competent department the sponsor and the drug regulatory department in a timely manner as required. The principal investigator will conduct a cumulative review of all adverse events on a regular basis. When necessary a researcher meeting will be convened to evaluate the risks and benefits of the study. In a double - blind trial emergency unblinding can be carried out if necessary to ensure the safety and rights of the subjects.

数据管理委员会：

Data Managemen Committee：

有

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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