ChiCTR2500097314 版本V1.0 版本创建时间2025/02/17 16:04:34 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：

ChiCTR2500097314 

最近更新日期：

Date of Last Refreshed on：

2025-02-17 16:03:01 

注册时间：

Date of Registration：

2025-02-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

一项口服 NEPA 胶囊在预防顺铂化疗后鼻咽癌患者化疗后恶心呕吐的有效性和安全性的回顾性研究

Public title：

A Retrospective Study on the Efficacy and Safety of Oral NEPA Capsules in Preventing Nausea and Vomiting in Nasopharyngeal Carcinoma Patients after Cisplatin Chemotherapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项口服 NEPA 胶囊在预防顺铂化疗后鼻咽癌患者化疗后恶心呕吐的有效性和安全性的回顾性研究

Scientific title：

A Retrospective Study on the Efficacy and Safety of Oral NEPA Capsules in Preventing Nausea and Vomiting in Nasopharyngeal Carcinoma Patients after Cisplatin Chemotherapy

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：

罗海清 

研究负责人：

罗海清 

Applicant：

Luo Haiqing 

Study leader：

Luo Haiqing 

申请注册联系人电话：

Applicant telephone：

+86 137 2919 6345

研究负责人电话：

Study leader's telephone：

+86 137 2919 6345

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：

hqluo@126.com

研究负责人电子邮件：

Study leader's E-mail：

hqluo@126.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：

广东省湛江市霞山区人民大道南57号

研究负责人通讯地址：

广东省湛江市霞山区人民大道南57号

Applicant address：

57 Renmin Avenue South, Xiashan District, Zhanjiang, Guangdong, China

Study leader's address：

57 Renmin Avenue South, Xiashan District, Zhanjiang, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

524000

研究负责人邮政编码：

Study leader's postcode：

524000

申请人所在单位：

广东医科大学附属医院

Applicant's institution：

Affiliated Hospital of Guangdong Medical University

研究负责人所在单位：

广东医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guangdong Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

LY2024-188

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：

广东医科大学附属医院机构审查伦理委员会

Name of the ethic committee：

Review Ethics Committee of Affiliated Hospital of Guangdong Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-08-23 00:00:00

伦理委员会联系人：

梁政

Contact Name of the ethic committee：

Zheng Liang

伦理委员会联系地址：

广东省湛江市霞山区人民大道南57号

Contact Address of the ethic committee：

57 Renmin Avenue South, Xiashan District, Zhanjiang, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 759 238 6971

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：

广东医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guangdong Medical University

研究实施负责（组长）单位地址：

广东省湛江市霞山区人民大道南57号

Primary sponsor's address：

57 Renmin Avenue South, Xiashan District, Zhanjiang, 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

市(区县)：

湛江

Country：

China

Province：

Guangdong

City：

Zhanjiang

单位(医院)：

广东医科大学附属医院

具体地址：

霞山区人民大道南57号

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Address：

57 Renmin Avenue South, Xiashan District

经费或物资来源：

自筹经费

Source(s) of funding：

Self raised funds

Target disease：

Chemotherapy-Induced Nausea and Vomiting

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

研究NEPA胶囊在IC周期和CCRT周期中预防III-IVa期局部晚期鼻咽癌患者顺铂化疗后引起的CINV的有效性和安全性。  

Objectives of Study：

Study the efficacy and safety of NEPA capsules in preventing CINV caused by cisplatin chemotherapy in locally advanced stage III-IVa nasopharyngeal carcinoma patients during IC and CCRT cycles.

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病理诊断为III-IVa期局部晚期鼻咽癌（AJCC第8版）的患者，在我院完成全部基于顺铂的IC和CCRT治疗。 ② 年龄：18-75岁，ECOG成绩状态评分0-2。KPS得分≥80分。 ③ BMI在18.5到23.9kg/㎡. ④ 心功能、肾功能、肝功能和骨髓功能得到充分维持。 ⑤ 化疗开始前24小时没有恶心或呕吐的症状。 ⑥ 化疗前30天内，研究期间未使用吩噻嗪类药物或计划外使用吩恶嗪类药物作为抗精神病药物（患者可接受原氯哌嗪和其他吩噻津类药物的紧急止吐治疗）。 ⑦ 没有已知的对NEPA过敏。 ⑧ 能够阅读、理解和完成中文研究日记和问卷调查。

Inclusion criteria

1. A patient diagnosed with stage III-IVa locally advanced nasopharyngeal carcinoma (AJCC 8th edition) through pathological examination completed all cisplatin based IC and CCRT treatments at our hospital. 2. Age: 18-75 years old, ECOG score status score 0-2. KPS score >= 80 points. 3. BMI ranges from 18.5 to 23.9kg/㎡ 4. Heart function, kidney function, liver function, and bone marrow function are fully maintained. 5. There were no symptoms of nausea or vomiting 24 hours before the start of chemotherapy. 6. Within 30 days prior to chemotherapy, no phenothiazine drugs or unplanned use of phenothiazine drugs as antipsychotic drugs were used during the study period (patients may receive emergency antiemetic treatment with prochlorperazine and other phenothiazine drugs). 7. There is no known allergy to NEPA. 8. Ability to read, understand, and complete Chinese research diaries and surveys.

排除标准：

1. 在开始化疗之前，某些疾病已被证明具有恶心和呕吐的潜在风险，如严重的认知障碍、有症状性中枢神经系统疾病史、慢性酒精中毒、活动性消化性溃疡、胃肠道梗阻、高钙血症等。 2. 过去6个月内已知的心脏病，如心律失常、不受控制的充血性心力衰竭或急性心肌梗死。 3. 在化疗开始前24小时内，患者接受了任何潜在的催吐或止吐药物。 4. 患者在1周内接受强效或中度CYP3A4抑制剂治疗，并在治疗前或治疗后1-5天内接受任何CYP3A4诱导剂治疗。 5. 化疗前一周出现呕吐或恶心的患者已接受手术或腹部放射治疗（膈下）或盆腔区域，并在化疗前两天内接受止吐药物治疗。 6. 数据丢失和临床数据不完整。

Exclusion criteria：

1. Before starting chemotherapy, certain diseases have been shown to have potential risks of nausea and vomiting, such as severe cognitive impairment, history of symptomatic central nervous system disorders, chronic alcoholism, active peptic ulcers, gastrointestinal obstruction, hypercalcemia, etc. 2. Known heart diseases within the past 6 months, such as arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction. 3. Within 24 hours prior to the start of chemotherapy, the patient received any potential emetic or antiemetic medication. 4. The patient receives potent or moderate CYP3A4 inhibitor treatment within one week and any CYP3A4 inducer treatment within 1-5 days before or after treatment. 5. Patients who experience vomiting or nausea one week before chemotherapy have undergone surgery or abdominal radiation therapy (subphrenic) or pelvic area, and received antiemetic medication within two days before chemotherapy. 6. Data loss and incomplete clinical data.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-01 00:00:00 至 To 2025-01-01 00:00:00  

干预措施：

Interventions：

组别：

1组 （NEPA胶囊+奥氮平+地塞米松）

样本量：

123

Group：

Group 1 (single dose of NEPA + olanzapine + dexamethasone)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

2组 （福沙匹坦+帕洛诺司琼+奥氮平+地塞米松）

样本量：

123

Group：

Group 2 (fosaprepitant 150mg + palonosetron 0.75mg + olanzapine + dexamethasone)

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

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)：

 湛江 

Country：

China 

Province：

Guangdong 

City：

Zhanjiang 

单位(医院)：

广东医科大学附属医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Hospital of Guangdong Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

化疗后恶心呕吐缓解率

指标类型：

主要指标

Outcome：

Relief rate of nausea and vomiting after chemotherapy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

化疗后恶心呕吐发生时间及严重程度

指标类型：

次要指标

Outcome：

Time and severity of nausea and vomiting after chemotherapy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

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：

Blinding：

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

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）：

使用中国临床试验注册中心的 ResMan 平台。网址：https://www.chictr.org.cn/resman/

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

Shared Date: Expected within 6 months after the end of the trial Metadata: including basic demographic information of participants (age, gender, race, etc.), disease diagnosis criteria, treatment plans, definition of observation indicators, and measurement methods. Metadata is provided in Excel spreadsheet format, with each row representing a variable and each column containing detailed information such as the variable's name, definition, data type, and value range.

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：

使用病例记录表采集信息

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

CRF design: According to the trial protocol: Design the CRF content based on the specific research objectives, inclusion and exclusion criteria, observation indicators, etc. of the clinical trial, ensuring that all necessary information is covered, such as patient basic information (name, age, gender, contact information, etc.), medical history, physical examination results, laboratory test data, treatment process, and adverse reactions. Follow standard specifications: Refer to relevant international and domestic standards and guidelines, such as the Clinical Data Exchange Standards Association (CDISC) standards, to ensure consistency and standardization in the definition, format, and coding of data items in CRF. Consider data entry and analysis requirements: Design a reasonable table structure and filling method to facilitate accurate data entry by researchers, as well as facilitate subsequent data management, statistical analysis, and quality control. CRF filling requirements: Accuracy, completeness, timeliness, and standardization Review and management of CRF: Review process: Establish a CRF review mechanism, where researchers, data administrators, and others review completed CRFs to ensure data quality. Any issues discovered during the review process should be promptly reported to the filling personnel for correction. Version control: If CRF is modified or updated during the trial process, the version number, modification date, and modification content should be recorded to ensure that all researchers are using the latest version of CRF. Preservation and archiving: Paper CRFs should be properly preserved and organized in numerical order for easy reference and retrieval; Electronic CRF should be backed up to prevent data loss.

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：

  2025-02-17 16:03:01