艾灸对卵巢癌化疗后白细胞Ⅱ度抑制患者免疫细胞的影响及机制研究

注册号:

Registration number:

AMCTR-ION-18000223 

注册号获得时间:

Date of releasing the registration number:

2018/11/12 22:02:16 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

艾灸对卵巢癌化疗后白细胞Ⅱ度抑制患者免疫细胞的影响及机制研究 

Public title:

Study on the effect and mechanism of moxibustion on immune cells in ovarian cancer patients with II degree leucopenia after chemotherapy 

研究课题的正式科学名称:

艾灸对卵巢癌化疗后白细胞Ⅱ度抑制患者免疫细胞的影响及机制研究 

Scientific title:

Study on the effect and mechanism of moxibustion on immune cells in ovarian cancer patients with II degree leucopenia after chemotherapy 

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:

刘泽宇 

研究负责人:

黄金昶 

Applicant:

Zeyu Liu 

Study leader:

Jinchang Huang 

申请注册联系人电话:

Applicant telephone:

13718560318 

研究负责人电话:

Study leader's telephone:

13910801918 

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:

13718560318@139.com 

研究负责人电子邮件:

Study leader's E-mail:

zryhhuang@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:

北京市朝阳区北三环东路11号北京中医药大学 

研究负责人通讯地址:

北京市朝阳区安外小关街51号北京中医药大学第三附属医院 

Applicant address:

No.11 North 3rd Ring East Road, Chaoyang District, Beijing, Beijing University of Chinese Medicine 

Study leader's address:

No. 51 Xiao Guan Street, Chaoyang District, Beijing, The third Hospital affiliated to Beijing University of Chinese Medicine 

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:

北京中医药大学 

Applicant's institution:

Beijing University of Chinese Medicine 

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:

BZYSY-2018YJKT-01 

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:

北京中医药大学第三附属医院科研伦理委员会 

Name of the ethic committee:

IRB of The third Hospital affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-30 

研究实施负责(组长)单位:

北京中医药大学第三附属医院 

Primary sponsor:

The third Hospital affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市朝阳区安外小关街51号 

Primary sponsor's address:

No. 51 Xiao Guan Street, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学第三附属医院

具体地址:

北京市朝阳区安外小关街51号

Institution
hospital:

The third Hospital affiliated to Beijing University of Chinese Medicine

Address:

No. 51 Xiao Guan Street, Chaoyang District, Beijing

经费或物资来源:

院级课题 

Source(s) of funding:

hospital level project 

研究疾病:

化疗后白细胞减少症 

Target disease:

leucopenia after chemotherapy 

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:

其它 

Study phase:

Other 

研究目的:

探索艾灸对卵巢癌化疗后白细胞Ⅱ度抑制患者免疫细胞的影响及机制 

Objectives of Study:

To explore the effect and mechanism of moxibustion on immune cells in ovarian cancer patients with II degree leucopenia after chemotherapy 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. 经组织病理学或细胞病理学确诊的卵巢上皮型浆液腺癌或粘液腺癌患者,且分期Ⅱ-Ⅲ期; 2. 化疗方案:紫杉醇175mg/m^2,静脉滴注>3h;卡铂 AUC 5~6 静脉滴注>1h;每3周重复; 3. 年龄在50-65岁之间; 4. 受试者体能状况尚可,卡氏评分(Karnofsky)≥80分; 5. 骨髓抑制程度:Ⅱ级:白细胞(2.0~2.9)×10^9/L; 6. 受试者依从性好,同意并签署知情同意书。 

Inclusion criteria

1. Ovarian epithelial serous adenocarcinoma or mucinous adenocarcinoma confirmed by histopathology or cytopathology, with stages II-III; 2. Chemotherapy regimen: paclitaxel 175 mg/m^2, intravenous drip > 3 h; carboplatin AUC 5-6 intravenous drip > 1 h; repeated every 3 weeks; 3. the age is between 50-65 years old. 4. the physical condition of the subjects is acceptable, and the Karnofsky score is more than 80 points. 5. the degree of bone marrow suppression: Grade II: white blood cells (2 ~ 2.9) x 10^9/L; 6. the subjects agreed well and agreed to sign informed consent. 

排除标准:

1. 其它原因导致的白细胞减少症; 2. 妊娠及意向妊娠或哺乳期妇女; 3. 合并严重心、肝、脾、肺、肾、骨等重要脏器功能损害者; 4. 有认知障碍或严重精神疾病者; 5. 合并血液系统疾病者; 6. 合并自身免疫病者; 7. 合并严重感染或者慢性感染性疾病者; 8. 治疗期间应用其他骨髓抑制药物或升白药物; 9. 试验前1月内接受过艾灸治疗者; 10. 正参加其他临床试验者。 

Exclusion criteria:

1. leucopenia caused by other causes; 2. pregnant and intentional pregnancy or lactation women; 3. combined with severe heart, liver, spleen, lung, kidney, bone and other important organ damage; 4. those with cognitive impairment or severe mental illness; 5. patients with hematological diseases; 6. patients with autoimmune diseases; 7. those with severe infection or chronic infectious diseases; 8. those who use other myelosuppressive drugs or leukocytosis drugs during the treatment; 9. those who had received moxibustion treatment within 1 months before participating in the study; 10. participating in other clinical trials. 

研究实施时间:

Study execute time:

From2018-11-15To 2020-12-31 

干预措施:

Interventions:

组别:

艾灸组

样本量:

6

Group:

Moxibustion group

Sample size:

干预措施:

艾灸

干预措施代码:

Intervention:

Moxibustion

Intervention code:

组别:

阳性药物组

样本量:

6

Group:

Positive drug group

Sample size:

干预措施:

注射rhG-CSF

干预措施代码:

Intervention:

inject rhG-CSF

Intervention code:

组别:

观察组

样本量:

6

Group:

Observation group

Sample size:

干预措施:

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):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学第三附属医院 

单位级别:

三级甲等 

Institution
hospital:

The third Hospital affiliated to Beijing University of Chinese Medicine  

Level of the institution:

Three Level of First-class 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan friendship hospital  

Level of the institution:

Three Level of First-class 

测量指标:

Outcomes:

指标中文名:

免疫组库测序

指标类型:

主要指标 

Outcome:

(Immune Repertoire sequencing

Type:

Primary indicator 

指标中文名:

淋巴细胞亚群分类

指标类型:

次要指标 

Outcome:

Lymphocyte Subgroup Classification

Type:

Secondary indicator 

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

complete blood count

Type:

Secondary indicator 

指标中文名:

血生化

指标类型:

副作用指标 

Outcome:

blood biochemical examination

Type:

Adverse events 

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

随机数表

性别:

女性

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

Random number table

Gender:

Female

盲法:

Blinding:

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):

向研究者索取

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

Ask researchers for information

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):

epidata

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

epidata

创建人:

Creater Name:

 2018-11-06
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