ChiCTR2400091859 版本V1.0 版本创建时间2024/11/05 10:47:18 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：

 ChiCTR2400091859 

最近更新日期：

Date of Last Refreshed on：

 2024-11-05 10:46:26 

注册时间：

Date of Registration：

 2024-11-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

针灸改善中晚期宫颈癌同步放化疗患者恶 心呕吐的效果观察

Public title：

Effects of acupuncture on chemoradiotherapy-induced nausea and vomiting in patients with intermediate and advanced cervical cancer: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针灸改善中晚期宫颈癌同步放化疗患者恶 心呕吐的效果观察

Scientific title：

Effects of acupuncture on chemoradiotherapy-induced nausea and vomiting in patients with intermediate and advanced cervical cancer: a randomized controlled trial

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：

任毅 

研究负责人：

张愉 

Applicant：

Ren Yi 

Study leader：

Zhang Yu 

申请注册联系人电话：

Applicant telephone：

 +86 152 9163 8326

研究负责人电话：

Study leader's
telephone：

+86 152 9163 8002

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：

 renyionly@163.com

研究负责人电子邮件：

Study leader's E-mail：

 joy_zhangyu@163.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：

汉中市南郑区大河坎镇东昌路8号

研究负责人通讯地址：

汉中市汉台区康复路22号

Applicant address：

8 Dongchang Road, Nanzhen District, Hanzhong, Shaanxi, China

Study leader's address：

22 Kangfu Road, Hantai District, Hanzhong, Shaanxi, 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：

汉中市中心医院

Applicant's institution：

Hanzhong Hospital of TCM

研究负责人所在单位：

汉中市中心医院

Affiliation of the Leader：

Hanzhong Central Hospital

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：

 NO: IRB2018-T

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：

汉中市中心医院伦理委员会

Name of the ethic committee：

Ethics Committee of Hanzhong Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-07-18 00:00:00

伦理委员会联系人：

骆毅

Contact Name of the ethic committee：

Luo Yi

伦理委员会联系地址：

汉中市汉台区康复路22号

Contact Address of the ethic committee：

22 Kangfu Road, Hantai District, Hanzhong, Shaanxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 177 6219 8311

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：

汉中市中心医院

Primary sponsor：

Hanzhong Central Hospital

研究实施负责（组长）单位地址：

汉中市汉台区康复路22号

Primary sponsor's address：

22 Kangfu Road, Hantai District, Hanzhong, Shaanxi, 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)：

陕西省

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

汉中市中心医院

具体地址：

汉中市汉台区康复路22号

Institution
hospital：

Hanzhong Central Hospital

Address：

22 Kangfu Road, Hantai District, Hanzhong, Shaanxi, China

经费或物资来源：

汉中市中心医院院级科研基金

Source(s) of funding：

esearch fund project of Central Hospital of Hanzhong

研究疾病：

中晚期宫颈癌  

Target disease：

intermediate and advanced cervical 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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

宫颈癌是最常见的女性生殖系统恶性肿瘤之一，在全球女性恶性肿瘤中发病率仅次于乳腺癌。我国每年新发病例13.5万，居我国妇科恶性肿瘤首位，是妇女因癌症死亡的主要原因。宫颈癌早期治疗以手术为主，中晚期以化疗、放疗为主，但因单纯化疗无法对较大体积的局部肿瘤组织实施有效控制、单纯放疗无法阻断肿瘤细胞的扩散与转移，故美国癌症研究会（American Association for Cancer Research, AACR）推荐同步放化疗（Concurrent Chemoradiotherapy Treatment, CCRT）作为中晚期宫颈癌患者的标准治疗模式。恶心呕吐被认为是CCRT过程中最使病人感到极度痛苦和神经衰弱的不良反应，已影响到患者治疗的依从性和耐受性。美国国立综合癌症网络（National Comprehensive Cancer Network, NCCN）推荐使用5-羟色胺（5-hypdroxytryptamine, 5-HT3）受体拮抗剂治疗肿瘤同步放化疗所致恶心呕吐（chemoradiotherapy-induced nausea and vomiting, C-RINV），但其在使用过程中会增加患者头痛、便秘、疲劳的风险。目前，有超过60%的国家癌症研究所将针灸应用于癌症症状管理，相关研究也证实针灸对控制肿瘤单纯化疗、单纯放疗所致恶心呕吐有一定疗效，但对于针灸控制中晚期宫颈癌C-RINV尚无报道。据此，本研究采用严格的临床随机对照试验，与5-HT3受体拮抗剂比较，对针刺控制中晚期宫颈癌同步放化疗所致恶心呕吐的临床疗效进行观察及评价，以便为临床应用提供依据。  

Objectives of Study：

According to the ‘Third National Retrospect Spot-Check of Death-Causation’, the top three diseases with leading cause of death in China are cerebrovascular disease, cancer, and respiratory disease . Meanwhile, compared with the rest of world, the number of cancer cases in China comes in the first place at 25.49% As one of the most common malignancies of the female reproductive system, cervical cancer is second only to breast cancer in the incidence of female malignancies worldwide. China reports 135,000 new cases on cervical cancer annually, ranking first among gynecological malignant tumors across the country, which is the main cause of cancer-related death for women. At present, the treatment of cervical cancer has gradually shifted from a single model to a comprehensive one with multiple approaches, and concurrent chemoradiotherapy treatment (CCRT) has become a standardized treatment for cervical cancer. Nausea and vomiting are rated as highly distressing and debilitating adverse effects in patients receiving chemotherapy and radiotherapy. In the recent three decades, the quantity and quality of research in chemotherapy-induced nausea and vomiting (CINV) are constantly increasing, but only few studies have examined prophylaxis for radiotherapy-induced nausea and vomiting (RINV), not to mention chemoradiotherapy-induced nausea and vomiting (C-RINV). American Society of Clinical Oncology (ASCO) recommends patients undergoing CCRT to receive prophylactic antiemetic therapy based on the intensity of post-chemotherapy emesis (level of evidence and strength of recommendation, 2A), unless a higher emetogenic risk exists from the planned radiation therapy (level of evidence and strength of recommendation, 3). The latest National Comprehensive Cancer Network (NCCN) Guidelines recommends 5-hypdroxytryptamine (5-HT3) and neurokinin 1 (NK1) receptor antagonists as antiemetic therapies for preventing and treating nausea and vomiting which were proved to be effective. However, caution should be taken when using these drugs for CCRT because of high risk of headache, fatigue, and constipation which can make cancer patients suffer more. A recent review also restates that patients may still experience nausea when using 5-HT3 receptor antagonists. Therefore, researchers and patients are seeking new methods to control C-RINV such as non-drug therapies. Traditional Chinese Medicine (TCM) is getting increasing attention, and the World Health Organization (WHO) announced that TCM will be recognized in its influential global medical compendium. As a typical TCM therapy, acupuncture has served human healthcare for at least 2,500 years. Nowadays, more than 60% of National Cancer Institutes (NCI) incorporate acupuncture into cancer symptom management. The main mechanisms of acupuncture prevention and treatment of nausea and vomiting are as follows: acupuncture can affect gastrointestinal motility by regulating central and peripheral substance P (SP), regulate digestive function by reducing peripheral 5-HT3, and then affect the secretion of brain-gut peptides (e.g. Motilin, Cholecystokinin, Somatostain) by acting on the brain-gut axis, thus regulating the gastrointestinal function. Furthermore, acupuncture is able to protect gastric mucosa by increasing the content calcitonin gene-related peptide (CGPR) and prostaglandin E2 (PGE2). Although a general consensus has been reached that acupuncture is helpful for CINV and RINV, this conclusion is primarily based on a number of studies that predate current antiemetic guidelines. No acupuncture trial on different specific types of C-RINV exists whether for acute, delayed, or anticipatory, and this is why whether acupuncture owns benefits beyond current standard treatments remains unknown. Therefore, the aim of this study was to investigate whether acupuncture is safe and feasible for C-RINV comparing to conventional antiemetics.

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）年龄20-80岁。（2）经病理诊断明确的II、III期宫颈癌患者。（3）美国东部肿瘤协作组织（Eastern Cooperative Oncology Group, ECOG）体力状态评分0-2分。（4）预期生存期>6个月。（5）实验室检查无异常：①肝肾功能正常：总胆红素<1.5×ULN; 谷丙转氨酶、谷草转氨酶<2.5×ULN; 肌酐<1.25×ULN; ②14天内未输血: 血红蛋白>90g/L; 中性粒细胞绝对数≥1.5×109; 血小板≥1.5×109。（6）治疗前1周内未使用任何止吐药。（7）患者知情，愿意参与本研究并签署同意书。

Inclusion criteria

(1) aged 20– 80 years; (2) with defined pathological diagnosis of cancer; (3) Eastern Cooperative Oncology Group (ECOG) score between 0 and 2; (4) expected lifetime longer than 6 months; (5) with normal laboratory check (adequate hepatorenal function: TBIL < 1.5 × ULN; ALT, AST < 2.5 × ULN; Cr < 1.25 × ULN; no blood transfusion in the past 14 days: HB > 90g/L; ANC ≥ 1.5×109; PLT ≥ 1.5×109); and (6) no history of antiemetic medication in the past 24 h.

排除标准：

（1）怀孕或哺乳期。（2）因颅内转移瘤或全身其他转移引起恶心呕吐者。（3）严重肠梗阻或者大量腹水或者合并有重要脏器功能不全引起恶心呕吐者。（4）有精神及感知功能缺陷的患者。（5）有凝血病、血小板减少症或其他出血性疾病的患者。（6）败血症或菌血症患者。（7）在针刺刺激区域有淋巴水肿的患者。（8）畏惧针刺或对针灸针过敏的患者。（9）研究者判断其他可能影响本研究进行及结果判定的情况。

Exclusion criteria：

(1) antiemetic treatment or persistent emesis within 24 h before CCRT; (2) pregnant or lactating women; (3) intractable vomiting caused by malignant brain metastases, intracranial hypertension, brain tumors, cerebrovascular disease, or other reasons; (4) intractable vomiting caused by digestive tract obstruction, severe liver or renal dysfunction, or uncontrolled pleural effusion or ascites; (5) psychogenic or sensing dysfunction; (6) coagulopathy, thrombocytopenia, or other bleeding disorders; (7) sepsis or bacteremia; (8) lymphedema in the acupuncture stimulation area; or (9) allergy to stainless steel needles or those who are afraid of acupuncture stimulation.

研究实施时间：

Study execute time：

从 From 2018-07-18 00:00:00至 To 2023-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-07-26 00:00:00 至 To 2022-08-15 00:00:00

干预措施：

Interventions：

组别：

针灸组

样本量：

 100

Group：

acupuncture group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

acupuncture

Intervention code：

组别：

药物组

样本量：

 100

Group：

Tropisetron group

Sample size：

干预措施：

药物

干预措施代码：

Intervention：

Tropisetron

Intervention code：

组别：

空白组

样本量：

 100

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

  

Country：

China

Province：

Shaanxi

City：

单位(医院)：

 汉中市中心医院 

单位级别：

 三甲医院 

Institution
hospital：

Hanzhong Central Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

常见不良反应评价标准

指标类型：

主要指标

Outcome：

the Common Terminology Criteria for Adverse Events (CTCAE)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

卡氏评分

指标类型：

主要指标

Outcome：

the Karnofsky Score (KPS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

简化营养偏好问卷

指标类型：

主要指标

Outcome：

the Simplified National Appetite Questionnaire (SNAQ)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医院焦虑抑郁量表

指标类型：

主要指标

Outcome：

the Hospital Anxiety and Depression Scale (HADS)

Type：

Primary 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：

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 80 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）：

本研究分为3组：治疗组（针灸组）、对照组（药物组）、空白组。应用SAS version 9.1.3软件按照1:1:1的比例生成随机序列。将随机序列装入密闭、不透光的信封中。纳入病例时，按受试者入组顺序依次打开信封，按随机序列进行分组。

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

In this study, block randomization at a 1:1:1 ratio was carried out according to the sequence generated with SAS version 9.1.3 software (SAS Institute Inc., Carry, Nc, USA). The randomization was concealed using sealed envelopes and numbered consecutively according to patient entry number. These envelopes were kept in the doctors’ office and were opened by the designated researcher after each participant’s consent. No binding was performed.

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：

对治疗方案不知情的研究人员从受试者处收集数据。 对数据收集不知情的研究人员将数据录入数据库。 对数据录入不知情的研究人进行结果分析。 由于治疗方案的差别性， 本研究无法做到盲病人及操作者。

Blinding：

Researchers blinded to the treatment regimen collect data from the subjects. Researchers who are blinded to data collection enter data into a database. Results analysis was performed for researchers who were blinded to data entry. Due to the differences in treatment regimens, it was not possible to blind patients and operators in this study.

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

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）：

采用临床试验公共管理平台并向公众开放查询 临床试验公共管理平台ResMan (www.medresman.org.cn)

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

ResMan (www.medresman.org.cn)

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：

(1)对治疗方案不知情的研究人员从受试者处收集数据。对数据收集不知情的研究人员将数据录入数据库。对数据录入不知情的研究人进行结果分析. (2)采集数据保存于Electronic Data Capture, EDC。

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

(1)Researchers who were not aware of the treatment regimen collected data from the subjects.Researchers who were not aware of the data collection entered it into a database.The results of the study were analyzed for uninformed data entry subjects. (2)Data will be collected and saved in Electronic Data Capture (EDC).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-11-05 10:46:26