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山茶油按摩预防大肠癌患者抗癌药物致手足综合征的疗效:一项随机、双盲、安慰剂对照临床试验

注册号：

Registration number：

ITMCTR2025000368

最近更新日期：

Date of Last Refreshed on：

2025-02-19

注册时间：

Date of Registration：

2025-02-19

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

山茶油按摩预防大肠癌患者抗癌药物致手足综合征的疗效:一项随机、双盲、安慰剂对照临床试验

Public title：

Efficacy of Camellia Oil Massage in Preventing Chemotherapy-Induced Hand-Foot Syndrome in Patients with Colorectal Cancer: A Randomized Double-Blind Placebo-Controlled Clinical Trial

注册题目简写：

山茶油按摩防大肠癌药物手足综合征：RCT

English Acronym：

Camellia Oil Massage Prevents HFS in CRC Patients: RCT

研究课题的正式科学名称：

中医护理技术预防化疗患者手足综合症效果观察

Scientific title：

Observation on the Effect of Traditional Chinese Medicine Nursing Techniques in Preventing Hand-Foot Syndrome in Chemotherapy Patients

研究课题的正式科学名称简写：

中医护理防化疗HFS效果观察

Scientific title acronym：

Observation on TCM Nursing Techniques for Preventing HFS in Chemotherapy Pts

研究课题代号(代码)：

Study subject ID：

XB2024194

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：

薛霞香

研究负责人：

薛霞香

Applicant：

XiaXiang Xue

Study leader：

XiaXiang Xue

申请注册联系人电话：

Applicant telephone：

13600801120

研究负责人电话：

Study leader's telephone：

13600801120

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：

47012004@qq.com

研究负责人电子邮件：

Study leader's E-mail：

xiaxiangxue@fjzlhospital.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.fjzl.com.cn/

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：

中国福建省福州市晋安区福马路420号福建省肿瘤医院急诊室

研究负责人通讯地址：

中国福建省福州市晋安区福马路420号福建省肿瘤医院急诊室

Applicant address：

Emergency Room Fujian Cancer Hospital No. 420 Fuma Road Jin'an District Fuzhou City Fujian Province China

Study leader's address：

Emergency Room Fujian Cancer Hospital No. 420 Fuma Road Jin'an District Fuzhou City Fujian Province China

申请注册联系人邮政编码：

Applicant postcode：

350014

研究负责人邮政编码：

Study leader's postcode：

350014

申请人所在单位：

福建医科大学肿瘤临床医学院，福建省肿瘤医院

Applicant's institution：

Clinical Oncology School of Fujian Medical UniversityFujian Cancer Hospital

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：

K2024-248-01

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：

福建省肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Fujian Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/6/21 0:00:00

伦理委员会联系人：

陈妹妹

Contact Name of the ethic committee：

Meimei Chen

伦理委员会联系地址：

中国福建省福州市晋安区福马路420号福建省肿瘤医院伦理办公室

Contact Address of the ethic committee：

Ethics Office Fujian Cancer Hospital No. 420 Fuma Road Jin'an District Fuzhou City Fujian Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0591-62752181

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fjzlec@163.com

研究实施负责（组长）单位：

福建医科大学肿瘤临床医学院，福建省肿瘤医院

Primary sponsor：

Clinical Oncology School of Fujian Medical UniversityFujian Cancer Hospital

研究实施负责（组长）单位地址：

中国福建省福州市晋安区福马路420号福建省肿瘤医院急诊室

Primary sponsor's address：

Emergency Room Fujian Cancer Hospital No. 420 Fuma Road Jin'an District Fuzhou City Fujian 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)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou

单位(医院)：

福建省肿瘤医院

具体地址：

中国福建省福州市晋安区福马路420号福建省肿瘤医院急诊室

Institution
hospital：

Fujian Cancer Hospital

Address：

Emergency Room Fujian Cancer Hospital No. 420 Fuma Road Jin'an District Fuzhou City Fujian Province China

经费或物资来源：

福建中医药大学

Source(s) of funding：

Fujian University of Traditional Chinese Medicine

研究疾病：

手足综合征

研究疾病代码：

Target disease：

Hand-foot syndrome

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：

本研究旨在评估手足按摩联合茶油护理在预防和减轻化疗患者手足综合症（HFS）方面的效果

Objectives of Study：

The aim of this study is to evaluate the effectiveness of hand-foot massage combined with tea oil nursing in preventing and alleviating hand-foot syndrome (HFS) among chemotherapy patients.

药物成份或治疗方案详述：

山茶油按摩方案：首先确保环境保持安静、舒适和温暖，营造放松的氛围，准备按摩油（茶油）、手套（根据实际需要）、干净毛巾以及温水等物品；操作员需穿着整洁干净的衣服，保持手部卫生，指甲应剪短，必要时还需佩戴手套；进入操作步骤时，操作员需向患者详细解释按摩的目的和步骤，以获得患者的理解和积极配合；随后，让患者以舒适的姿势坐或躺在护理床或椅子上，并脱掉鞋袜，露出手足；用温水清洗患者的手足，并在按摩前后进行操作者手部清洁和消毒，以确保按摩过程的卫生；接着是茶油的涂抹，将适量茶油倒在手心，轻轻揉搓至手心温暖后，均匀涂抹在患者的手足部位，确保覆盖全面；掌心按摩采用双手拇指以画圈方式轻轻按压，指尖按摩则从指尖开始沿指骨方向向掌心轻轻按压，手背按摩则是用双手拇指在手背上由手腕向指尖方向轻轻按压，手腕部分则用手环绕一圈，进行一压一松的按压；随后嘱患者做握拳运动，双手握拳数秒后松开，反复进行10次；足部按摩步骤与手部相似，包括脚掌、足趾和足背的按摩，以及足部松紧运动；完成按摩后，用干净毛巾轻轻擦去多余的茶油，让患者稍作休息，穿好鞋袜，调整姿势。在按摩过程中，首先注意初次按摩前应进行茶油皮肤过敏测试，以确保患者无过敏反应，若按摩过程中出现皮肤发红、瘙痒等过敏症状，应立即停止按摩并通知医生。其次，按摩时应注意力度适中，避免过度用力引起患者不适。同时，按摩过程中应与患者保持沟通，根据其反馈调整按摩手法和力度。每日进行2次山茶油按摩手足，每次持续20分钟。

Description for medicine or protocol of treatment in detail：

Camellia Oil Massage Protocol: First ensure the environment is quiet comfortable and warm creating a relaxing atmosphere. Prepare items such as massage oil (camellia oil) gloves (as needed) clean towels and warm water. The operator should wear neat and clean clothes maintain hand hygiene keep nails trimmed and wear gloves if necessary. Before starting the massage the operator should explain the purpose and steps of the massage to the patient in detail to gain their understanding and active cooperation. Subsequently have the patient sit or lie down in a comfortable position on the treatment bed or chair and remove their shoes and socks to expose their hands and feet. Clean the patient's hands and feet with warm water and clean and disinfect the operator's hands before and after the massage to ensure hygiene throughout the process. Next apply camellia oil. Pour an appropriate amount of camellia oil into the palm of your hand gently rub until the palm feels warm and then evenly apply it to the patient's hands and feet ensuring comprehensive coverage. For palm massage use both thumbs to gently press in a circular motion. For fingertip massage start at the fingertips and gently press along the direction of the finger bones towards the palm. For the back of the hand use both thumbs to gently press from the wrist towards the fingertips. For the wrist use one hand to encircle it and perform a pressing and releasing motion. After that instruct the patient to perform fist clenching exercises by clenching their fists for a few seconds and then releasing them repeating this 10 times. The foot massage steps are similar to those for the hands including massaging the sole toes and top of the foot as well as foot relaxation and tightening exercises. After completing the massage gently wipe away any excess camellia oil with a clean towel allow the patient to rest for a while put on their shoes and socks and adjust their position. During the massage first note that a camellia oil skin allergy test should be performed before the initial massage to ensure the patient has no allergic reactions. If skin redness itching or other allergic symptoms occur during the massage immediately stop the massage and notify a doctor. Second pay attention to using moderate pressure during the massage to avoid causing discomfort to the patient due to excessive force. At the same time maintain communication with the patient during the massage and adjust the massage technique and pressure based on their feedback. Perform camellia oil hand and foot massages twice a day each lasting 20 minutes.

纳入标准：

经病理确诊为大肠癌患者；首次使用含奥沙利铂、卡培他滨等药物，预计生存期3月以上；年龄在18至75岁之间；无严重的手足皮肤疾病：如严重的湿疹、感染等；患者或其法定代理人自愿签署知情同意书，愿意参与研究并配合完成整个研究过程。

Inclusion criteria

Patients with colorectal cancer confirmed by pathology; first-time use of medications containing oxaliplatin capecitabine etc.;Estimated survival time of more than 3 months aged; between 18 and 60 years; no severe skin diseases on the hands and feet such as severe eczema or infections; patients or their legal representatives voluntarily signed the informed consent form willing to participate in the study and cooperate to complete the entire research process.

排除标准：

合并其他严重疾病：如严重的心、肝、肾功能不全，精神疾病等；有已知对茶油或按摩操作过敏的患者；妊娠或哺乳期妇女；不愿意或无法按照要求接受护理和随访的患者。

Exclusion criteria：

Patients with other severe comorbidities such as severe heart liver or kidney dysfunction psychiatric disorders etc.; patients with known allergies to camellia oil or massage procedures; pregnant or lactating women; patients unwilling or unable to receive care and follow-up as required.

研究实施时间：

Study execute time：

从From 2024-07-09

至To      2026-01-14

征募观察对象时间：

Recruiting time：

从From 2024-07-09

至To      2026-01-04

干预措施：

Interventions：

组别：

对照组

样本量：

50

Group：

control group

Sample size：

干预措施：

实施安慰剂按摩

干预措施代码：

B

Intervention：

Perform placebo massage

Intervention code：

组别：

试验组

样本量：

50

Group：

Experimental group

Sample size：

干预措施：

实施山茶油按摩

干预措施代码：

A

Intervention：

Perform Camellia Oil Massage

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou

单位(医院)：

福建省肿瘤医院

单位级别：

三级甲等

Institution/hospital：

Fujian Cancer Hospital

Level of the institution：

Grade A tertiary (or Class 3A depending on the context which usually refers to the highest level of hospitals in China based on a tiered evaluation system)

测量指标：

Outcomes：

指标中文名：

生活质量

指标类型：

主要指标

Outcome：

Quality of Life

Type：

Primary indicator

测量时间点：

研究开始前、化疗第 2 周期结束后、化疗第 4 周期结束后以及化疗结束后

测量方法：

访问

Measure time point of outcome：

Before the study began after the completion of the 2nd chemotherapy cycle after the completion of the 4th chemotherapy cycle and after the completion of all chemotherapy cycles.

Measure method：

visit

指标中文名：

手足综合征的发生率和严重程度

指标类型：

主要指标

Outcome：

Incidence and severity of hand-foot syndrome

Type：

Primary indicator

测量时间点：

在每个化疗周期开始前以及化疗周期结束后

测量方法：

访问、观察

Measure time point of outcome：

Before the commencement of each chemotherapy cycle and after the completion of each chemotherapy cycle.

Measure method：

Visit and observation

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 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）：

随机数字表法，由数据管理人员准备一个包含大量随机数字的表格，这些数字通常是按照某种随机算法生成的。根据研究所需的样本量，从随机数字表中选取相应数量的数字作为随机序列。这些随机数字将用于将参与者分配到实验组和对照组中。

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

The data manager prepares a table containing a large number of random numbers which are typically generated based on a certain random algorithm. Depending on the sample size required for the study a corresponding number of digits are selected from the random number table to form a random sequence. These random numbers will be used to allocate participants to the experimental group and the control group.

盲法：

准备 100 份按摩油包，50包内放装满与茶油相似的按摩油瓶，另 50 包内放装满茶油的茶油瓶，这两种瓶子予以 1-100 编号，100瓶油包混在一起，以开盲盒方式分给研究对象。研究人员及研究对象均不知道分到哪个组，达到双盲。

Blinding：

Prepare 100 massage oil packets with 50 packets containing bottles filled with massage oil similar to tea oil and the other 50 packets containing bottles filled with actual tea oil. Both types of bottles are numbered from 1 to 100. The 100 oil packets are mixed together and distributed to the study participants in a blind box manner. Neither the researchers nor the participants know which group they are assigned to achieving double blinding.

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）：

2026年6月

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

June 2026

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：

调查表、数据管理表

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

Survey form data management sheet

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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