ChiCTR2300078681 版本V1.0 版本创建时间2023/12/15 08:56:14 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：

 ChiCTR2300078681 

最近更新日期：

Date of Last Refreshed on：

 2023-12-15 08:56:07 

注册时间：

Date of Registration：

 2023-12-15 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

肺康复训练联合个体化营养干预改善非小细胞肺癌患者临床结局的前瞻性随机对照研究

Public title：

A prospective randomized controlled study of pulmonary rehabilitation training combined with individualized nutritional intervention to improveclinical outcomes in patients with non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肺康复训练联合个体化营养干预改善非小细胞肺癌患者临床结局的前瞻性随机对照研究

Scientific title：

A prospective randomized controlled study of pulmonary rehabilitation training combined with individualized nutritional intervention to improveclinical outcomes in patients with non-small cell lung 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：

郑婧 

研究负责人：

李建军 

Applicant：

Jing Zheng 

Study leader：

Jianjun Li 

申请注册联系人电话：

Applicant telephone：

 +86 136 7765 5496

研究负责人电话：

Study leader's
telephone：

+86 158 2594 0185

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：

 312850153@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 676349171@qq.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：

重庆市巴南区龙洲湾街道渝南大道659号

研究负责人通讯地址：

重庆市巴南区龙洲湾街道渝南大道659号

Applicant address：

659 Yunan Avenue, Longzhouwan Street, BanarDistrict, Chongqing

Study leader's address：

659 Yunan Avenue, Longzhouwan Street, BanarDistrict, Chongqing

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：

重庆市巴南区人民医院

Applicant's institution：

People's Hospital of Chongqing Banan District

研究负责人所在单位：

重庆市巴南区人民医院

Affiliation of the Leader：

People's Hospital of Chongqing Banan District

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：

 (2022)伦审(004)号

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：

重庆市巴南区人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Banan District People's Hospital of Chongqing

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-01-25 00:00:00

伦理委员会联系人：

徐政国

Contact Name of the ethic committee：

Zhengguo Xu

伦理委员会联系地址：

重庆市巴南区龙洲湾街道渝南大道659号伦理委员会办公室

Contact Address of the ethic committee：

Ethics Committee Office, 659 Yunan Avenue.Longzhouwan Street, Banan District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 157 3605 6904

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：

重庆市巴南区人民医院

Primary sponsor：

People's Hospital of Chongqing Banan District

研究实施负责（组长）单位地址：

重庆市巴南区龙洲湾街道渝南大道659号

Primary sponsor's address：

659 Yunan Avenue, Longzhouwan Street, BanarDistrict, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

巴南区

Country：

China

Province：

Chongqing

City：

BanarDistrict

单位(医院)：

重庆市巴南区人民医院

具体地址：

重庆市巴南区龙洲湾街道渝南大道659号

Institution
hospital：

People's Hospital of Chongqing Banan District

Address：

659 Yunan Avenue, Longzhouwan Street, BanarDistrict, Chongqing

经费或物资来源：

重庆市巴南区科学技术局

Source(s) of funding：

Science and Technology Bureau of Banan District, Chongqing

研究疾病：

肺癌  

Target disease：

lung 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：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

肺癌是我国及世界范围内发病率和死亡率最高的恶性肿瘤之一，手术仍是早期肺癌的首选治疗方式。由于患者术后呼吸面积减少、肺功能降低，以及营养不足等综合因素，严重影响了患者术后恢复及生活质量。肺康复训练作为一种非药物辅助治疗手段正逐渐应用于肺癌患者中，能一定程度改善患者的肺功能、提高患者运动耐力等；而合理的营养支持不仅可以改善患者营养状况，还能减少并发症、提高患者生活质量。本项目拟开展一项前瞻性、单中心、随机对照临床干预研究：纳入拟实施胸腔镜单肺叶切除的非小细胞肺癌患者160例，随机分为2组，对照组给予常规治疗及宣教，干预组在常规治疗基础上，进行肺康复训练，同时给予个体化营养干预；密切随访12周，观察给予联合干预后对肺癌患者生活质量、术后并发症、营养状况、肺功能、运动能力等的影响，明确这种联合疗法对肺癌患者的益处，同时为肺癌术后加速康复方法提供临床实践依据。  

Objectives of Study：

Lung cancer is one of the malignant tumors with the highest morbidity and mortality in China and worldwide. Surgery is still the preferred treatment for early stage lung cancer. The postoperative recovery and quality of life of patients are seriously affected by the reduction of breathing area, lung function, and malnutrition. Pulmonary rehabilitation training, as a non-drug adjuvant therapy, is gradually applied to patients with lung cancer, which can improve lung function and exercise endurance to a certain extent. Reasonable nutritional support can not only improve the nutritional status of patients, but also reduce complications and improve the quality of life of patients. A prospective, single-center, randomized controlled clinical intervention study was conducted. 160 patients with non-small cell lung cancer undergoing thoracoscopic lobectomy were randomly divided into two groups. The control group was given routine treatment and education, and the intervention group was given pulmonary rehabilitation training and individualized nutritional intervention on the basis of routine treatment. The patients were followed up for 12 weeks to observe the effects of combined intervention on the quality of life, postoperative complications, nutritional status, lung function and exercise capacity of patients with lung cancer, so as to clarify the benefits of this combined therapy for patients with lung cancer, and to provide clinical practice basis for enhanced recovery after lung cancer surgery.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准:(1)经病理学诊断明确为原发性非小细胞肺癌者；（2）虽未行病理诊断但结合影像学表现，临床高度怀疑肺癌者；（3）根据中国肺癌诊疗指南中规定，有施行胸腔镜单肺叶切除手术+系统淋巴结清扫术指证，且经常规检查，未发现手术禁忌证；（4）至少包含一个高危因素：①年龄≥75岁或吸烟量≥400年/支；②男性年龄>60岁同时合并吸烟；③女性年龄>70岁同时合并吸烟；④肺功能检查提示以下至少一项内容：第一秒用力呼气容积(FEV1)＜1.0L；一秒率（FEV1/FVC）＜50%；呼气峰流量(PEF) <250 L/min;⑤支气管舒张试验阳性；(5)患者同意参加本研究，同时签署知情同意书。

Inclusion criteria

Inclusion criteria :(1) primary non-small cell lung cancer confirmed by pathological diagnosis; (2) high suspicion of lung cancer based on imaging findings without pathological diagnosis; (3) According to the Chinese guidelines for the diagnosis and treatment of lung cancer, there are indications for thoracoscopic lobectomy and systematic lymph node dissection, and no surgical contraindications were found through routine examination; (4) at least one high risk factor: ① age ≥75 years or smoking ≥400 years/cigarette; ② Male age >60 years old with smoking; ③ women over 70 years old with smoking history; ④ Pulmonary function test showed at least one of the following: forced expiratory volume in 1 second (FEV1) < 1.0L; FEV1/FVC < 50%; Peak expiratory flow (PEF) <250 L/min; ⑤ Bronchial dilation test was positive; (5) Patients agreed to participate in this study and signed an informed consent form.

排除标准：

排除标准：有下列任何情形之一者： (1)术中快速冰冻或术后石蜡病理检查结果不符合原发性非小细胞肺癌诊断;(2)经评估不宜施行胸腔镜手术或手术中转开胸者;(3)术中发现需要改变手术方式，需行联合肺叶切除、全肺切除或肺动脉和支气管袖式成形肺叶切除术等;(4)术中出血量超过1000 ml者;(5)试验期间有非计划再次手术者；(6)不配合肺康复训练或拒绝执行营养计划者；(7)合并严重肝肾功能不全、肠梗阻、消化道出血等；(8)正在参与其他临床研究者；(9)拒绝签署知情同意书者。

Exclusion criteria：

Exclusion criteria: (1) The results of intraoperative frozen section or postoperative paraffin pathological examination did not meet the diagnosis of primary non-small cell lung cancer; (2) those who were evaluated as unsuitable for thoracoscopic surgery or were converted to thoracotomy; (3) Combined lobectomy, pneumonectomy or pulmonary artery and bronchial sleeve lobectomy were needed during the operation. (4) intraoperative blood loss more than 1000 ml; (5) patients with unplanned reoperation during the study period; (6) those who do not cooperate with pulmonary rehabilitation training or refuse to implement nutrition plan; (7) complicated with severe hepatic and renal insufficiency, intestinal obstruction, gastrointestinal bleeding, etc. (8) participating in other clinical investigators; (9) those who refused to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-01-26 00:00:00 至 To 2023-01-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 80

Group：

Control group

Sample size：

干预措施：

给予常规术前准备及宣教，按计划施行手术，术后给予常规处理及宣教，病情稳定后出院，于术后第4周、第8周、第12周定期随访。整个研究过程，营养师全程不参与营养干预，临床医生根据临床实际情况决定在不同情况下是否营养支持及营养支持的形式。

干预措施代码：

Intervention：

The patients were given routine preoperative preparation and education, the operation was carried out according to the plan, and the patients were given routine treatment and education after the operation. The patients were discharged after the condition was stable, and the patients were followed up regularly at the 4th, 8th and 12th weeks after the operation. Dietitians did not participate in nutritional intervention during the whole study, and clinicians decided whether to receive nutritional support and the form of nutritional support in different situations according to the actual clinical situation.

Intervention code：

组别：

试验组

样本量：

 80

Group：

Experimental Group

Sample size：

干预措施：

术前2周开始进行肺康复训练，同时由营养师给患者行营养咨询、膳食指导，按照营养支持参照标准，根据患者营养状况制定个体化营养支持方案。与对照组一样，给予术前准备后，按计划施行手术，给予常规术后处理，鼓励术后患者早期的被动活动、循序渐进的床边坐站、缓慢步行等；术后继续由营养师给予营养支持方案。病情稳定后办理出院，鼓励患者在术后2周开始进行肺康复训练，在术后第4周、第8周、第12周进行随访，营养师全程参与患者营养方案的制定，同时给患者行营养宣教、膳食指导等。

干预措施代码：

Intervention：

Two weeks before surgery, patients began pulmonary rehabilitation training, and nutritional counseling and dietary guidance were given by nutritionists. According to the reference standard of nutritional support, individualized nutritional support programs were formulated according to the nutritional status of patients. The same as the control group, after preoperative preparation, the operation was carried out according to the plan, and routine postoperative treatment was given. Early passive activities, gradual bedside sitting and standing, and slow walking were encouraged. Postoperative nutritional support was given by dietitians. The patients were encouraged to begin pulmonary rehabilitation training at 2 weeks after surgery, and were followed up at 4 weeks, 8 weeks and 12 weeks after surgery. Nutritionists participated in the formulation of the patient's nutrition plan, and provided nutrition education and dietary guidance to the patients.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

 巴南区 

Country：

China

Province：

Chongqing

City：

BanarDistrict

单位(医院)：

 重庆市巴南区人民医院 

单位级别：

 三甲医院 

Institution
hospital：

People's Hospital of Chongqing Banan District

Level of the institution：

Tertiary A hospital

测量指标：

Outcomes：

指标中文名：

肺癌特异性生活质量量表

指标类型：

主要指标

Outcome：

Functional Assessment of Cancer Treatment-Lung, FACT-L

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能

指标类型：

次要指标

Outcome：

Pulmonary function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6分钟步行距离

指标类型：

次要指标

Outcome：

6-minute walk distance 6MWD

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者主观整体营养评估

指标类型：

次要指标

Outcome：

patient-generated subjective global assessment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后肺部并发症

指标类型：

次要指标

Outcome：

Postoperative pulmonary complications

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蛋白质类指标（TP、ALB、HB）

指标类型：

次要指标

Outcome：

Protein indicators(TPALBHB)

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：

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 18 岁 years
最大 Max age 85 岁 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）：

根据随机数表生成随机数，制作并密封号牌。患者入院后随机选择信封。信封内编号为奇数的患者纳入试验组，偶数的患者纳入对照组。

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

Random numbers were generated according to the random number table, a number plate was prepared and sealed. Patients randomly selected envelopes after admission. If the number plate in the envelope was odd, they were included in the test group, and patients with even numbers were included in the control group.

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：

Blinding：

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）：

网址：https://kdocs.cn/l/cbUtlpfwq2DL

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

Website: https://kdocs.cn/l/cbUtlpfwq2DL

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：

在SPSS23.0系统建立数据集管理

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

Data set management was established in SPSS23.0 system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-12-15 08:56:07