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水滤红外线A(wIRA)光疗在预防和治疗鼻咽癌患者调强放射治疗配合化疗所致口腔黏膜炎的随机、对照临床研究
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注册号:

Registration number:

ChiCTR-INR-16009053 

最近更新日期:

Date of Last Refreshed on:

2016-08-21 

注册时间:

Date of Registration:

2016-08-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

水滤红外线A(wIRA)光疗在预防和治疗鼻咽癌患者调强放射治疗配合化疗所致口腔黏膜炎的随机、对照临床研究 

Public title:

The efficacy of water-filtered infrared-A (wIRA) in the prevention and treatment of oral mucositis in patients with nasopharyngeal carcinoma receiving intensity modulated radiotherapy (IMRT) and chemotherapy: a randomized controlled clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

水滤红外线A(wIRA)光疗在预防和治疗鼻咽癌患者调强放射治疗配合化疗所致口腔黏膜炎的随机、对照临床研究 

Scientific title:

The efficacy of water-filtered infrared-A (wIRA) in the prevention and treatment of oral mucositis in patients with nasopharyngeal carcinoma receiving intensity modulated radiotherapy (IMRT) and chemotherapy: a randomized controlled clinical 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:

柯梁汝 

研究负责人:

郭翔 

Applicant:

Liangru Ke 

Study leader:

Xiang Guo 

申请注册联系人电话:

Applicant telephone:

+86 13632379024 

研究负责人电话:

Study leader's telephone:

+86 13902251881 

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:

dk13kezai@126.com 

研究负责人电子邮件:

Study leader's E-mail:

guoxiang@sysucc.org.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.sysucc.org.cn/ 

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:

广东省广州市越秀区东风东路651号 

研究负责人通讯地址:

广东省广州市越秀区东风东路651号 

Applicant address:

651 East Dongfeng Road, Guangzhou, Guangdong, China 

Study leader's address:

651 East Dongfeng Road, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510060 

研究负责人邮政编码:

Study leader's postcode:

510060 

申请人所在单位:

中山大学肿瘤防治中心 

Applicant's institution:

Sun Yat-sen University Cancer Center 

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:

B2016-015-01 

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:

中山大学肿瘤防治中心伦理委员会 

Name of the ethic committee:

The Ethical Committee of Sun Yat-sen University Cancer Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-15 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中山大学肿瘤防治中心 

Primary sponsor:

Sun Yat-sen University Cancer Center 

研究实施负责(组长)单位地址:

广东省广州市越秀区东风东路651号 

Primary sponsor's address:

651 East Dongfeng Road, Guangzhou, Guangdong 

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):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学肿瘤防治中心

具体地址:

广东省广州市越秀区东风东路651号

Institution
hospital:

Sun Yat-sen University Cancer Center

Address:

651 East Dongfeng Road, Guangzhou, Guangdong

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

鼻咽癌患者调强放射治疗配合化疗所致口腔黏膜炎 

Target disease:

oral mucositis in patients with nasopharyngeal carcinoma receiving intensity modulated radiotherapy (IMRT) and chemotherapy 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评价wIRA光疗在预防和治疗鼻咽癌(NPC)患者的调强放疗配合化疗所致口腔黏膜炎(OM)的作用 

Objectives of Study:

To evaluate the efficacy of water-filtered infrared-A (wIRA) in the prevention and treatment of oral mucositis in patients with nasopharyngeal carcinoma receiving intensity modulated radiotherapy (IMRT) and chemotherapy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1) 年龄大于18岁小于65岁 2) 体能状况(ECOG)评分0~1分 3) 病理确诊为鼻咽癌并计划接受调强放射治疗(IMRT)配合化疗 4) 在筛选的前14天内进行以下实验室检测评价骨髓、肝、肾功能:: i. --血红蛋白 > 9.0 g/dl ii. --绝对中性粒细胞计数(ANC) >1,500/mm3 iii. --血小板计数> 100,000/μl iv. --总胆红素=< 1.5倍正常值上限(ULN) v. --谷丙转氨酶及谷草转氨酶 < 2ULN(正常值上限),凝血酶原时间(PT)国际标准化比值 /凝血酶原时间(PTT)< 1.5ULN,血清肌酐 < 1.5ULN。 5) 签署知情同意书。 

Inclusion criteria

1. Patients between 18-65 years old; 2. ECOG score 0-1; 3. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, who are planning to receive IMRT combined with chemotherapy; 4. With normal bone marrow, liver and renal function 14 days before enrollment as followed: 1) HGB ≥ 9g/dL; 2) ANC ≥1.5*10^9/L, PLT ≥ 100*10^9/L , TBIL≤ 1.5xULN; ALT and AST ≤ 2×ULN; PT/APTT ≤ 1.5×ULN; Creatinine clearance < 1.5xULN; 5. Patients must offer signed informed consent. 

排除标准:

1) 远处转移 2) 无法清楚直视口腔黏膜炎病灶的张口困难 3) 既往接受过头颈部放射治疗 4) 既往接受过化疗 5) 急性腮腺炎、急性中耳炎、白内障、青光眼、癫痫患者 6) 任何影响愈合能力的疾病,如糖尿病、免疫缺陷 7) 治疗过程同时使用光敏药物(例如卟啉、四环素、磺胺、补骨脂素、吩噻嗪等) 8) 心脏病病史:充血性心力衰竭>NYHA心功能分级2级;活动性冠心病 (参加研究前6个月心肌梗塞的患者可以进入本试验);心律失常需要抗心律失常治疗(允许使用beta受体阻滞剂及地高辛)或者未控制的高血压 9) HIV感染史 10) 除口腔黏膜炎外的严重活动性感染(> 2级,NCI-CTC v.4.0) 11) 具有出血倾向的证据或者病史的患者 12) 怀孕或者哺乳期女性患者.育龄期女性在接受治疗的前7天内必须进行妊娠试验,以排除妊娠.参加本研究的男性及女性患者在试验的过程中及试验结束后两周都必须采取充分的屏障避孕措施进行避孕 13) 参加本研究的4周内接受过本研究以外的其他光治疗者 14) 不同意签署知情同意书. 

Exclusion criteria:

1. Patients with distant metastasis; 2. Patients unable to be observed the oral mucositis due to difficulty in opening mouth; 3. With history of radiotherapy to head and neck; 4. With history of chemotherapy; 5. Patients with acute parotitis, acute otitis media, cataract and epilepsy; 6. Patients with any disease that might influence healing, such as diabetes mellitus or immunity deficient; 7. Patients undertaking photosensitive drugs, including porphyrin, tetracycline, sulfonamide, meladinin, thiophenylamine and so on; 8. Patients with history of heart disease: congestive heart-failure > NYHA grade 2, active coronary heart disease (patients suffered from myocardial infarction 6 months before enrollment could be accepted), arrhythmia that needs anti-arrhythmia therapy (beta receptor blocker and digoxin could be accepted) or uncontrolled hypertension; 9. HIV infection; 10. With severe uncontrolled infections (>grade 2, NCI-CTC v.4.0); 11. With history or tendency to bleeding or medical disorders; 12. In pregnant or lactating Female; 13. With history of photo-therapy in 4 weeks before enrollment; 14. Patients without signing informed consent. 

研究实施时间:

Study execute time:

From2016-08-22To 2016-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

55

Group:

treatment group

Sample size:

干预措施:

水滤红外线光疗

干预措施代码:

Intervention:

wIRA treatment

Intervention code:

组别:

对照组

样本量:

55

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

regular treatment

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):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学肿瘤防治中心 

单位级别:

三级甲等 

Institution
hospital:

Sun Yat-sen University Cancer Center  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

口腔黏膜炎的级别

指标类型:

主要指标 

Outcome:

grade of oral mucositis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

止痛药物的使用

指标类型:

次要指标 

Outcome:

The need of analgetic

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重变化

指标类型:

次要指标 

Outcome:

change of body weight

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标 

Outcome:

VAS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠外营养的使用

指标类型:

次要指标 

Outcome:

the need of parenteral nutrition

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口腔黏膜炎导致的治疗中断

指标类型:

主要指标 

Outcome:

treatment interruption induced by oral mucositis

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

随机分组由中山大学附属肿瘤防治中心临床试验中心通过计算机产生随机数字,分层(2层)分段。

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

Random assignment is done (via sealed envelopes) by the Clinical Trials Centre, Sun Yat-sen University Cancer Center.

盲法:

开放性

Blinding:

open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

临床试验公共管理平台ResMan

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

IPD will be accessable via ResMan

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:

中山大学肿瘤防治中心保存和管理

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

The data will be stored and managed by Sun Yat-sen University.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-21
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