今天是:2019-06-25 星期二

心康饮预防乳腺癌放射治疗相关心脏疾病前瞻性随机对照临床研究
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注册号:

Registration number:

ChiCTR1900023226 

最近更新日期:

Date of Last Refreshed on:

2019-05-17 

注册时间:

Date of Registration:

2019-05-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

心康饮预防乳腺癌放射治疗相关心脏疾病前瞻性随机对照临床研究 

Public title:

Prospective Randomized Controlled Clinical Study for Heart Health Beverage in Preventing Radiotherapy-related Cardiac Diseases in Breast Cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心康饮预防乳腺癌放射治疗相关心脏疾病前瞻性随机对照临床研究 

Scientific title:

Prospective Randomized Controlled Clinical Study for Heart Health Beverage in Preventing Radiotherapy-related Cardiac Diseases in Breast Cancer 

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:

祁伟祥 

研究负责人:

许赪 

Applicant:

Qi Weixiang 

Study leader:

Xu Cheng 

申请注册联系人电话:

Applicant telephone:

+86 021-64370045 

研究负责人电话:

Study leader's telephone:

+86 021-64370045 

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:

qwx12055@rjh.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

xucheng60@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:

上海市黄浦区瑞金二路197号 

研究负责人通讯地址:

上海市黄浦区瑞金二路197号 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院 

Applicant's institution:

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of 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:

2018-225 

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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-29 

伦理委员会联系人:

王一峰 

Contact Name of the ethic committee:

Wang Yifeng 

伦理委员会联系地址:

上海市黄浦区瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

上海交通大学医学院附属瑞金医院 

Primary sponsor:

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市黄浦区瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

黄浦区瑞金二路197号

Institution
hospital:

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Address:

197 Second Ruijin Road, Huangpu District

经费或物资来源:

上海市综合医院中西医结合专项建设 

Source(s) of funding:

Special Construction of Integrated Traditional Chinese and Western Medicine in Shanghai General Hospital 

研究疾病:

乳腺癌 

Target disease:

breast 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:

研究目的:

评价心康饮预防乳腺癌放射治疗相关心脏疾病的疗效和安全性。 

Objectives of Study:

Investigate the efficacy and safety of heart health beverage in preventing radiotherapy-related cardiac diseases in breast cancer. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1 签署知情同意书; 2 年龄≥18岁,≤70岁,KPS≥70; 3 患者均接受50Gy/25Fx术后辅助放射治疗; 4 接受左侧乳腺癌保乳手术+腋窝淋巴结清扫/前哨淋巴结活检/腋淋巴结取样;或接受左侧乳腺癌改良根治术:T1-2伴N1-3,T3-4伴任何淋巴结状态; 5 术后病理明确是浸润性乳腺癌;手术切缘(-); 6 在辅助或者新辅助化疗阶段,接受过蒽环类和/或紫杉类化疗药物,和/或赫赛汀靶向治疗; 7 抗肿瘤全身治疗前及放疗前LVEF≥50%。 

Inclusion criteria

1. Willingness to sign the written informed consent document. 2. Female patients aged between 18 and 70 years with left side of breast cancer, Karnofsky performance score ≥70 points; 3. Breast cancer who has indication to receive adjuvant radiotherapy (50Gy/25Fx); 4. Pathological confirm of invasive breast cancer with negative surgical margin; 5. Patients received Cardiotoxic drugs in adjuvant or neoadjuvant stage; 6. Cardiac function: all of the patients were required to have a left ventricular ejection fraction (LVEF) >50%; 7. Patients had a life expectancy of 12 months or more. 

排除标准:

1 发现远处转移; 2 右侧乳腺癌; 3 T1-2,N0已接受改良根治术; 4 治疗前已有心肌缺血损伤史、先天性心脏病、心肌病及心功能不全等病史; 5 肝、肾功能受损(ALT、AST、血清肌酐水平大于正常上限值2倍); 6 合并急性感染; 7 妊娠或哺乳期妇女,精神障碍者; 8 伴有其他恶性肿瘤,包括同时和既往发现的恶性肿瘤; 9 对本研究药物过敏者; 10 正在参加其它药物试验者; 11 既往胸部放疗病史。 

Exclusion criteria:

1. Disatant metastasis; 2. Right side of breast cancer; 3. T1-2N0, received Mastectomy 4. History of cardiac disease; 5. Hepatic functionalanine aminotransferase (ALT) and aspartate aminotransferase(AST)>2×ULN; 6. Severe or uncontrolled infection; 7. Women who are pregnant, breastfeeding; 8. History of other malignant disease; 9. Drug allergy to study drug; 10. Enrolled in other clinical trials; 11. History of Thoracic Radiotherapy. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-05-31 

干预措施:

Interventions:

组别:

研究组

样本量:

44

Group:

experimental group

Sample size:

干预措施:

心康饮

干预措施代码: