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Clinical study on the clinical efficacy and immune function of anticancer prescription combined with chemotherapy in patients with bladder cancer

注册号：

Registration number：

ITMCTR1900002444

最近更新日期：

Date of Last Refreshed on：

2019-07-06

注册时间：

Date of Registration：

2019-07-06

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

抗癌方联合化疗对膀胱癌术后患者的临床疗效及免疫功能的临床研究

Public title：

Clinical study on the clinical efficacy and immune function of anticancer prescription combined with chemotherapy in patients with bladder cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

抗癌方联合化疗对膀胱癌术后患者的临床疗效及免疫功能的研究

Scientific title：

Clinical study on the clinical efficacy and immune function of anticancer prescription combined with chemotherapy in patients with bladder cancer: A study protocol for a randomized controlled trial

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR1900024330 ; ChiMCTR1900002444

申请注册联系人：

于旭东

研究负责人：

张耀圣

Applicant：

Xudong Yu

Study leader：

Yaosheng Zhang

申请注册联系人电话：

Applicant telephone：

+86 19801206964

研究负责人电话：

Study leader's telephone：

+86 18134048843

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：

yuxudong9942@163.com

研究负责人电子邮件：

Study leader's E-mail：

zysjsgzs@163.com

申请单位网址(自愿提供)：

Study leader's 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：

中国北京市东城区海运仓5号

研究负责人通讯地址：

中国北京市东城区海运仓5号

Applicant address：

5 Haiyuncang, Dongcheng District, Beijing, China

Study leader's address：

5 Haiyuncang, Dongcheng District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

100700

研究负责人邮政编码：

Study leader's postcode：

100700

申请人所在单位：

北京中医药大学附属东直门医院泌尿外科

Applicant's institution：

Department of Urology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

DZMEC-KY-2019-43

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2019/6/3 0:00:00

伦理委员会联系人：

商建伟

Contact Name of the ethic committee：

Jianwei Shang

伦理委员会联系地址：

中国北京市东城区海运仓5号

Contact Address of the ethic committee：

5 Haiyuncang, Dongcheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 010 84012709

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sjw313@163.com

研究实施负责（组长）单位：

北京中医药大学附属东直门医院

Primary sponsor：

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

中国北京市东城区海运仓5号

Primary sponsor's address：

5 Haiyuncang, Dongcheng District, Beijing, 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)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学附属东直门医院

具体地址：

东城区海运仓5号

Institution
hospital：

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Address：

5 Haiyuncang, Dongcheng District

经费或物资来源：

横向课题项目支撑

Source(s) of funding：

Horizontal project support

研究疾病：

膀胱癌

研究疾病代码：

Target disease：

Bladder cancer

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

采用随机对照的研究方法，对膀胱肿瘤术后患者随机分为试验组及对照组，两组均治疗12周，随访36周，进行临床疗效的评价及相关实验指标的检测，寻找一种客观有效的膀胱肿瘤的治疗方法，从而使更多的患者受益。

Objectives of Study：

Randomized controlled study was used to randomly divide the patients with bladder tumor into the experimental group and the control group. The two groups were treated for 12 weeks and followed up for 36 weeks. The clinical efficacy evaluation and related experimental indicators were tested to find an objective and effective. The treatment of bladder tumors thus benefiting more patients.

药物成份或治疗方案详述：

将60例符合纳入标准的膀胱癌患者随机分为治疗组和对照组，每组各30例。两组患者均行TURPBT(经尿道膀胱肿瘤电切术）,对照组采用西医常规化疗方案加中药模拟剂；试验组在化疗方案的基础上口服中药进行治疗。中药组成：黄芪、当归、熟地黄、丹参、慈菇、僵蚕、蒲黄、半枝莲、三七，免煎颗粒，由北京中医药大学东直门医院用同一批号的药材统一制备提供，用防潮免煎袋包装。服用方法：每次用40摄氏度温开水50ml冲服，2次/天，早晚饭前40min 服用。两组治疗12周，随访36周。检测两组患者治疗前、后CD3+，CD4+及CD8+水平，计算CD4+/CD8+；采用放射免疫法检测膀胱肿瘤抗体；以及治疗前、后膀胱镜随机取膀胱粘膜活检组织进行组织形态学检测。治疗12周观察患者的生活质量状况变化以及肿瘤患者卡氏评分标准（KPS)评分变化、中医证候评分标准的变化，比较其临床疗效。患者在用药期间均禁烟禁酒、禁止食用辛辣刺激类食物。治疗期间所有患者均不能服用其他对本病有治疗效果或对疾病有影响的药物。

Description for medicine or protocol of treatment in detail：

Sixty patients with bladder cancer who met the inclusion criteria were randomized into a treatment group and a control group, 30 in each group. TURPBT (transurethral resection of bladder tumor) was performed in both groups. The control group was treated with Western medicine and chemotherapy. The experimental group was treated with oral Chinese medicine on the basis of chemotherapy. Chinese medicine composition: Astragalus, Angelica, Rehmannia glutinosa, Salvia miltiorrhiza, Sagittaria sinensis, silkworm, Puhuang, Scutellaria barbata, Sanqi, Fenjian granules, prepared by the same batch of medicinal materials from Dongzhimen Hospital of Beijing University of Chinese Medicine, with moisture protection Free from fried bag packaging. How to use: Take 50ml of warm water at 40 degrees Celsius twice a day, 2 times a day, 40 minutes before and after dinner. The two groups were treated for 12 weeks and followed up for 36 weeks. CD3+, CD4+ and CD8+ levels were measured before and after treatment in both groups, and CD4+/CD8+ was calculated. Bladder tumor antibodies were detected by radioimmunoassay; and bladder biopsy was randomly taken before and after treatment for histomorphometry. During the 12-week treatment, the changes in the quality of life of the patients and the changes in the KPS scores of the cancer patients and the changes in the TCM syndrome scores were observed, and the clinical efficacy was compared. During the medication, the patients were banned from alcohol and banned from spicy and stimulating foods. All patients during the treatment period are not allowed to take other drugs that have a therapeutic effect on the disease or have an effect on the disease.

纳入标准：

1 符合经尿道膀胱肿瘤电切术（TURPBT）后，且有病理学诊断恶性肿瘤； 2 卡氏评分标准（KPS）评分＞60分，预计生存期＞1年者； 3 25≤年龄≤80岁的患者； 4 辨证属于中医“气血两虚兼瘀毒内结”证型； 5 已自愿签署知情同意书者。

Inclusion criteria

1 In line with transurethral resection of bladder tumor (TURPBT), and pathological diagnosis of malignant tumors; 2 The Karnofsky Performance Status (KPS) score is >60 points, and the expected survival period is >1 year; 3 Aged 25 to 80 years; 4 Syndrome differentiation belongs to the syndrome type of "qi and blood deficiency and phlegm poisoning internal knot" in traditional Chinese medicine; 5 Those who have voluntarily signed an informed consent form.

排除标准：

1 过敏体质和对实验药品过敏者； 2 合并肾癌、膀胱结核、泌尿系结石患者； 3 合并其他恶性肿瘤患者； 4 血液系统疾病，凝血功能障碍及自身免疫性疾病患者； 5 合并严重心血管疾病、脑血管疾病，造血系统疾病，神经病患者； 6 试验前3个月参加过其他临床研究者； 对于以上6项排除标准，只要有1项满足即为符合排除标准，需要排除。

Exclusion criteria：

1 Allergic constitution and those who are allergic to experimental drugs; 2 Patients with renal cancer, bladder tuberculosis, and urinary calculi; 3 Combined with other malignant tumor patients; 4 Patients with blood system diseases, coagulopathy and autoimmune diseases; 5 Combined with severe cardiovascular disease, cerebrovascular disease, hematopoietic system disease, neuropathic patients; 6 Participated in other clinical researchers 3 months before the trial; For the above 6 exclusion criteria, as long as one of the criteria is met, the exclusion criteria are met and need to be excluded.

研究实施时间：

Study execute time：

从From 2019-07-01

至To      2022-03-31

征募观察对象时间：

Recruiting time：

从From 2019-07-01

至To      2021-12-01

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

西医常规化疗方案加中药模拟剂

干预措施代码：

M

Intervention：

Western medicine routine chemotherapy regimen plus traditional Chinese medicine simulan

Intervention code：

组别：

治疗组

样本量：

30

Group：

therapy group

Sample size：

干预措施：

西医常规化疗方案加抗癌方中药

干预措施代码：

N

Intervention：

Western medicine routine chemotherapy plus anti-cancer Chinese medicine

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学第一临床医院（东直门医院）

单位级别：

三级甲等

Institution/hospital：

The First Clinical Hospital of Beijing University of Chinese Medicine (Dongzhimen Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

膀胱癌症状综合评分

指标类型：

主要指标

Outcome：

Bladder cancer syndrome score

Type：

Primary indicator

测量时间点：

治疗前、治疗第4周、第8周

测量方法：

观察症状综合评分，临床症状主要包括尿频、尿急、尿痛、腰酸、恶心呕吐、呕干，从无到有，分值范围为0-6分，分值越高，表明患者症状越严重。

Measure time point of outcome：

Before treatment, treatment week 4, week 8

Measure method：

Observed symptom scores, clinical symptoms mainly include frequent urination, urgency, dysuria, backache, nausea and vomiting, vomiting, from scratch, the score ranged from 0 to 6 points, the higher the score, indicating the more severe the symptoms.

指标中文名：

肿瘤患者卡氏评分标准（KPS)评分

指标类型：

主要指标

Outcome：

Tumor patient Karnofsky Performance Status

Type：

Primary indicator

测量时间点：

治疗前、治疗第4周、第8周

测量方法：

采用卡氏评分标准（KPS）对功能量表、情感认知功能、症状量表、疼痛及总健康状况进行评分，评估日常生活质量。

Measure time point of outcome：

Before treatment, treatment week 4, week 8.

Measure method：

The functional scale, emotional cognitive function, symptom scale, pain, and general health status were scored using the Karsten Scale (KPS) to assess the quality of daily life.

指标中文名：

中医证候评分

指标类型：

次要指标

Outcome：

TCM syndrome score

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：

粘膜

组织：

膀胱

Sample Name：

mucosa

Tissue：

Bladder

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 25 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男性

Male

随机方法（请说明由何人用什么方法产生随机序列）：

对符合纳入标准的60名患者按照随机数字表分为治疗组和对照组各30例。 于旭东医师：请补充说明何人使用随机数字表产生随机序列。

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

According to the random number table, 60 patients who met the inclusion criteria were divided into treatment group and control group.

盲法：

双盲

Blinding：

Double blind

是否共享原始数据：

IPD sharing：

是

Yes

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）：

2021年5月 以学术论文的形式

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

May 2021 in the form of academic papers

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：

我们将应用病例记录表、电子采集和管理系统对研究过程中的数据进行采集和管理

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

We will use the case record form, electronic collection and management system to collect and manage the data during the research process.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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