掀针防治肿瘤患者化疗恶心呕吐的护理效果观察

注册号:

Registration number:

AMCTR-IPR-19000284 

注册号获得时间:

Date of releasing the registration number:

2019/7/19 23:33:26 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

掀针防治肿瘤患者化疗恶心呕吐的护理效果观察 

Public title:

Nursing effect of sputum acupuncture in the prevention and treatment of chemotherapy patients with nausea and vomiting 

研究课题的正式科学名称:

掀针防治肿瘤患者化疗恶心呕吐的护理效果观察 

Scientific title:

Nursing effect of sputum acupuncture in the prevention and treatment of chemotherapy patients with nausea and vomiting 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

周瑾 

研究负责人:

周瑾 

Applicant:

Jin Zhou 

Study leader:

Jin Zhou 

申请注册联系人电话:

Applicant telephone:

+86 18520088041 

研究负责人电话:

Study leader's telephone:

+86 18520088041 

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:

727120567@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

727120567@qq.com 

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:

广州市海珠区石榴岗路13号大院 

研究负责人通讯地址:

广州市海珠区石榴岗路13号大院 

Applicant address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China 

Study leader's address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, 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:

南方医科大学中西医结合医院 

Applicant's institution:

TCM-Intergrated of Southern Medical 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:

NFZXYEC-2018-03 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南方医科大学中西医结合医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Integrated Traditional Chinese and Western Medicine Hospital of Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-01 

研究实施负责(组长)单位:

南方医科大学中西医结合医院 

Primary sponsor:

TCM-Intergrated of Southern Medical University 

研究实施负责(组长)单位地址:

广州市海珠区石榴岗路13号大院 

Primary sponsor's address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学中西医结合医院

具体地址:

广州市海珠区石榴岗路13号大院

Institution
hospital:

TCM-Intergrated of Southern Medical University

Address:

13 Shiliugang Road, Haizhu District, Guangzhou, Guangdong, China

经费或物资来源:

院长基金 

Source(s) of funding:

Dean's Fund 

研究疾病:

肿瘤 

Target disease:

Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

评价掀针疗法对化疗患者恶心、呕吐症状的临床疗效;化疗患者提供一种简便易行的非药物临床治疗模式 

Objectives of Study:

To evaluate the clinical efficacy of sputum acupuncture therapy for nausea and vomiting in patients with chemotherapy; chemotherapy patients provide a simple and non-pharmaceutical clinical treatment model 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.病理组织学或细胞学确诊的恶性肿瘤,无化疗禁忌,依从性好; 2.预期生存>6个月; 3.功能状态评分1~2分,卡氏评分≥70分; 4.化疗前无恶心、呕吐、便秘、腹泻等消化道症状; 5.无心、脑、肾等重要脏器的器质性病变者; 6.根据病情需要至少连续进行2个周期相同方案的化疗。 7.患者及家属同意并签署知情同意书 

Inclusion criteria

1. Malignant tumors confirmed by histopathology or cytology, no chemotherapy contraindications, good compliance; 2. Expected survival >6 months; 2. The functional status score is 1 to 2 points, and the Karsten score is ≥ 70 points; 4. There are no gastrointestinal symptoms such as nausea, vomiting, constipation and diarrhea before chemotherapy; 5. organic lesions of important organs such as heart, brain and kidney; 6. According to the condition, at least 2 cycles of the same regimen of chemotherapy should be performed continuously; 7. Patients and their families agree and sign informed consent 

排除标准:

1. 化疗前已有非化疗因素引起的恶心、呕吐等胃肠道反应者; 2. 患者化疗前检查血尿常规、肝肾功能等异常; 3. 患者若第一周期结束后因非消化道反应问题需停止、减量化疗者; 4. 患者临床资料不完整,影响最终疗效判断者; 5. 恶性肿瘤颅脑转移、颅内高压、消化道梗阻所致的呕吐 6. 患者及家属未签字 7. 患者参加其他临床实验 

Exclusion criteria:

1.There are gastrointestinal reactions such as nausea and vomiting caused by non-chemotherapeutic factors before chemotherapy; 2. patients with abnormalities in hematuria, liver and kidney function before chemotherapy; 3. If the patient needs to stop or reduce chemotherapy due to non-digestive tract problems after the end of the first cycle; 4. The patient's clinical data is incomplete, affecting the final efficacy judgment; 5. malignant tumors, brain metastases, intracranial hypertension, vomiting caused by digestive tract obstruction 6. Patients and their families have not signed; 7. Patients participate in other clinical trials. 

研究实施时间:

Study execute time:

From2017-10-01To 2022-10-01 

干预措施:

Interventions:

组别:

试验验

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

常规护理治疗基础上给予掀针治疗

干预措施代码:

Intervention:

Routine nursing plus sputum acupuncture therapy

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规护理治疗

干预措施代码:

Intervention:

Routine nursing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

TCM-Intergrated of Southern Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总有效率

指标类型:

主要指标 

Outcome:

Total effect

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

NA

组织:

Sample Name:

NA

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 100 years

随机方法(请说明由何人用什么方法产生随机序列):

Excel产生随机数字表法

性别:

男女均可

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

Excel generates random number table method

Gender:

Both

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

试验结束后第3个月开始共享原始数据,公共平台临床试验公共管理平台ResMan (www.medresman.org)

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

The raw data will be shared 3 months after the end of the trial , including and the Clinical Trial Public Management Platform ResMan(www.medresman.org)

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

1.病例报告表的填写与移交 监查员作为申办方的指派代表,有权监查试验的进行是否遵循试验方案。病例报告表(CRF)由研究者填写,并做到数据的载入及时、完整、准确和清晰,且与原始资料一致。监查员对CRF进行核查,如有错误和遗漏,应及时要求研究者改正,并在改正处签名和注明日期且保持原有记录清晰可见。 CRF表经监查员核查无误后签字,将报告第一联移交临床试验数据管理员,进行数据录入与管理工作。对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录,收到时应有相应的签名,记录需妥善保存。 2.数据的录入与修改 数据录入与管理由南方医科大学卫生统计教研室负责。数据管理员在数据录入前需再次对CRF表进行核查,产生疑问时,以疑问解答表(DRQ)的形式通过临床监查员向研究者发出询问,研究者应尽快作出回答并返回。DRQ应需妥善保存。 数据管理员录入数据采用双份录入、相互核查原则。录入过程发现问题或意外情况,应做好登记并及时报告。并与主要研究者一起,按病例报告表中各指标数值的范围和相互关系拟定数据范围检查和逻辑检查内容。并编写相应的计算机程序,在输入前控制错误数据输入,如发现问题,必要时可再次发出DRQ。 原始CRF在按要求完成数据录入和核查后,按编号的顺序归档保存,并填有检索目录等,以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。所有原始档案应按《药物临床试验质量管理规范》的规定保存。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

1.completion and transfer of case report forms The inspector, as the designated representative of the applicant, has the right to monitor whether the trial is carried out in accordance with the trial program. The case report form is filled out by the researcher, and the data are recorded in a timely, complete, accurate and clear manner. In accordance with the original data, the inspector shall check the CRF, if there are any errors or omissions, ask the researcher to correct them in time, sign and date the correction and keep the original record clearly visible. The CRF form is signed by the inspector, and the first report is handed over to the clinical trial data manager for data entry and management. For the completed case report form, the researcher, the inspector, Data transfer between administrators should be a special record, received should be the corresponding signature, records should be properly preserved. 2.Data entry and modification Data entry and management is the responsibility of the Department of Health Statistics of Southern Medical University. The data administrator needs to check the CRF table again before the data is entered. In the form of a query form (DRQ), the researcher should answer the question as soon as possible and return to the .DRQ should be properly preserved through the clinical inspector. The data manager shall record the data in two copies and verify each other. The data entry process should be registered and reported in a timely manner, together with the leading researchers, if problems or accidents are found in the input process. The contents of data range check and logical check are worked out according to the range and interrelation of each index value in the case report table, and the corresponding computer program is written to control the wrong data input before input. If the problem is found, the DRQs can be sent out again if necessary. After completing the data entry and verification according to the requirements, the original CRF was archived and stored in the order.

创建人:

Creater Name:

 2019-07-18
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