ChiCTR2400088748 版本V1.0 版本创建时间2024/08/26 16:23:09 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：

ChiCTR2400088748 

最近更新日期：

Date of Last Refreshed on：

2024-08-26 16:23:02 

注册时间：

Date of Registration：

2024-08-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

家庭口服营养补充(ONS)用于慢性放射性肠损伤术后营养支持的前瞻性、随机对照临床研究

Public title：

Prospective, randomized controlled clinical study of home oral nutritional supplementation (ONS) for nutritional support after chronic radiation intestinal injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

家庭口服营养补充(ONS)用于慢性放射性肠损伤术后营养支持的前瞻性、随机对照临床研究

Scientific title：

Prospective, randomized controlled clinical study of home oral nutritional supplementation (ONS) for nutritional support after chronic radiation intestinal injury

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：

严婷 

研究负责人：

严婷 

Applicant：

Yan Ting 

Study leader：

Yan Ting 

申请注册联系人电话：

Applicant telephone：

+86 136 3132 6293

研究负责人电话：

Study leader's telephone：

+86 136 3132 6293

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：

350739343@qq.com

研究负责人电子邮件：

Study leader's E-mail：

350739343@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：

广州市员村二横路中山大学附属第六医院临床营养与微生态科

研究负责人通讯地址：

广州市员村二横路中山大学附属第六医院临床营养与微生态科

Applicant address：

Department of Clinical Nutrition and Microecology, The Sixth Affiliated Hospital of Sun Yat-sen University

Study leader's address：

Department of Clinical Nutrition and Microecology, The Sixth Affiliated Hospital of Sun Yat-sen University

申请注册联系人邮政编码：

Applicant postcode：

510000

研究负责人邮政编码：

Study leader's postcode：

510000

申请人所在单位：

中山大学附属第六医院

Applicant's institution：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第六医院

Affiliation of the Leader：

The Sixth Affiliated Hospital of Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024ZSLYESC-434

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：

中山大学附属第六医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-08-15 00:00:00

伦理委员会联系人：

吴倩

Contact Name of the ethic committee：

Wu Qian

伦理委员会联系地址：

中山大学附属第六医院科研科

Contact Address of the ethic committee：

Department of Scientific Research, the Sixth Affiliated Hospital of Sun Yat-sen University

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 3837 9764

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zslyllb@mail.sysu.edu.cn

研究实施负责（组长）单位：

中山大学附属第六医院

Primary sponsor：

The Sixth Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广州市员村二横路26号中山大学附属第六医院

Primary sponsor's address：

The Sixth Affiliated Hospital of Sun Yat-sen University, No. 26, Erheng Road, Yuancun, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

单位(医院)：

中山大学附属第六医院

具体地址：

广州市员村二横路26号中山大学附属第六医院

Institution
hospital：

The Sixth Affiliated Hospital of Sun Yat-sen University

Address：

The Sixth Affiliated Hospital of Sun Yat-sen University, No. 26, Erheng Road, Yuancun, Guangzhou

经费或物资来源：

自筹

Source(s) of funding：

self-raised

Target disease：

Radiation intestinal injury

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：

随机平行对照 

Study design：

Parallel 

研究目的：

针对CRE术后患者，评估家庭ONS对骨骼肌质量指数、握力、步速、营养状态、代谢情况、30天再入院率、并发症发病率和生活质量的影响。  

Objectives of Study：

The effects of home ONS on skeletal muscle mass index, grip strength, walking speed, nutritional status, metabolic status, 30-day readmission rate, complication incidence, and quality of life were evaluated in patients after CRE.

药物成份或治疗方案详述：

参与者在手术前进行基线评估，根据进入研究的顺序被随机分配到对照组或干预组。作为快速康复手术的一部分，在外科手术后第一周内立即开始对患者进行营养指导。两组受试者均将在胃肠功能恢复后尽快开始进食。两组受试者均接受营养师的饮食指导摄入流质，并且根据个体化耐受性逐渐增加，于术后7天±2内达到半流质，并被建议每天不少于1.2g/kg蛋白质的摄入量。 ONS组患者在出院后三个月内接受饮食建议与ONS联合治疗。饮食组建议主要目的是通过饮食方式增加患者的蛋白质和能量摄入。除常规膳食外，ONS的制剂选择的是整蛋白型营养粉。摄入量的预期每日剂量设定为711毫升，可分三次喝完，每次6勺粉约61.5克，加200毫升温水，调成237毫升的溶液。在三餐之间及晚餐后加餐。ONS 产品每一份含有约268大卡能量、32克碳水化合物、9克脂肪、13克蛋白质、2.8克纤维以及维生素和矿物质。在研究期间，所有患者都被要求在笔记本上写下他们每天的 ONS 摄入量，这将在门诊就诊时检查。如果当天受试者食用了>90%的ONS量，则被认为是合规的。对照组的患者仅接受与ONS组相同的饮食建议治疗。要求两组参与者在试验开始前和每次随访之间记录三天的饮食摄入情况（包括两个普通工作日和一个周末日）。 所有参与者在整个研究期间都接受了基于家庭的阻力锻炼计划，由专业的物理治疗师教授。阻力运动训练无需任何训练设备即可进行。一个训练课程包括五个练习： A:屈肘训练:手上拿一装满水的矿泉水瓶（约500毫升），手心向前，缓慢屈曲肘关节到最大范围，然后缓慢放下。 B:抬举训练：手上拿一装满水的矿泉水瓶（约500毫升），手心向着自己的身体，肘部保持伸直，缓慢抬起手至肩膀高度，然后缓慢放下。 C双手伸直，与肩同宽置于墙上，保持躯干竖直，缓慢弯曲手臂，让上身尽可能靠近墙壁，然后缓慢伸直手，回到最初位置。 D起立坐下训练:坐在一结实稳定的椅子上，躯干竖直，双脚着地，缓慢的站起来，然后又缓慢地坐下。 E踮脚训练:双手扶在桌面上，把双脚的脚后跟缓慢的提起，抬到自己能维持的最高点，然后缓慢地放下。 整个阻力训练在住院期间每周运动3天，出院后一周运动5天。根据个人自身状况选择以上部分或所有的项目进行，每个项目动作重复5-10遍为一组，2-3组/次，身体虚弱者可酌情减少每组的重复数量。抗阻运动进行30分钟。可不需一次性完成，一天累加达到这个建议时长即可。 随访 门诊就诊安排在出院后的第一个月、第三个月进行常规就诊。记录患者的饮食摄入量和依从性。患者在出院前由营养师定期告知患者在家中使用 ONS。此外，两组的所有患者每周通过电话或网络进行两次随访，以确认和指导对他们的个人治疗。 

Description for medicine or protocol of treatment in detail：

Participants were assessed at baseline before surgery and randomly assigned to a control or intervention group based on the order they entered the study. As part of the rapid recovery surgery, nutritional guidance for patients begins immediately within the first week after surgery. Both groups will begin eating as soon as gastrointestinal function is restored. Participants in both groups received dietary guidance from dietitians on fluid intake, and gradually increased according to individualized tolerance, reached semi-fluid within 7 days ±2 after surgery, and were advised to consume no less than 1.2g/kg of protein per day. Patients in the ONS group received dietary advice combined with ONS treatment within three months after discharge. The dietary group recommended that the primary objective was to increase the patient's protein and energy intake through dietary modalities. In addition to the regular diet, the preparation of ONS is a whole protein type nutrition powder. The expected daily dose of intake is set at 711 ml, which can be drunk in three times, each time 6 teaspoons of powder about 61.5 grams, plus 200 ml of warm water, adjusted to 237 ml of solution. Eat extra meals between meals and after dinner. ONS products contain approximately 268 calories per serving, 32 grams of carbohydrates, 9 grams of fat, 13 grams of protein, 2.8 grams of fiber, and vitamins and minerals. During the study, all patients were asked to write down their daily ONS intake in a notebook, which would be checked at an outpatient visit. If the subject consumed >90% of the ONS amount on that day, it was considered compliant. Patients in the control group received only the same dietary recommendations as those in the ONS group. Participants in both groups were asked to record their dietary intake for three days (including two regular weekdays and one weekend day) before the trial began and between each follow-up visit. All participants underwent a home-based resistance exercise program throughout the study period, taught by a professional physical therapist. Resistance exercise training can be performed without any training equipment. A training course consists of five exercises: A: Elbow bending training: Hold a mineral water bottle filled with water (about 500 ml), palm forward, slowly bend the elbow joint to the maximum extent, and then slowly lower. B: Lift training: Hold a mineral water bottle (about 500 ml) filled with water in your hands, palms toward your body, elbows kept straight, slowly lift your hands to shoulder height, and then slowly lower them. C Hold your hands straight, shoulder-width apart on the wall, keep your torso upright, slowly bend your arms so that your upper body is as close to the wall as possible, then slowly straighten your hands and return to the original position. D Stand up and sit down training: sit on a solid and stable chair, with your torso upright and your feet on the ground, stand up slowly, and then sit down slowly. E Tiptoe training: Hold your hands on the table, slowly lift the heels of your feet to the highest point you can maintain, and then slowly lower them. The entire resistance training was exercised 3 days a week during hospitalization and 5 days a week after discharge. Select some or all of the above items according to the individual's own situation. Repeat 5-10 times for each item as a group, 2-3 groups/times. The number of repetitions in each group can be reduced at the discretion of the weak. Resistance exercise for 30 minutes. You don't have to do it all at once, just add up to the recommended amount of time throughout the day. Follow-up visit Outpatient visits are scheduled for routine visits in the first and third months after discharge. Patients' dietary intake and adherence were recorded. Patients are regularly informed by a dietitian about the use of ONS at home prior to discharge. In addition, all patients in both groups were followed up twice a week by phone or online to confirm and guide their individual treatment. 

纳入标准：

CRE术后，NRS2002筛查阳性患者142人 （1）年龄18-70岁； （2）既往病理诊断为盆腔肿瘤（妇科、前列腺、泌尿系）； （3）盆腔放疗史，距离末次放疗结束至少6个月； （4）无原发肿瘤复发或转移； （5）全身功能状态ECOG评分在0-2分； （6）筛选时血清白蛋白≥30g/L; （7）CRE合并晚期并发症如肠梗阻、肠瘘等，需一期行病变肠管切除手术； （8）受试者及家属能够理解本研究方案，愿意参与并签署知情同意书。

Inclusion criteria

After CRE, 142 patients were screened positive for NRS2002 (1) Age 18-70 years old; (2) Previous pathological diagnosis of pelvic tumor (gynecology, prostate, urinary system); (3) History of pelvic radiotherapy, at least 6 months after the end of the last radiotherapy; (4) No recurrence or metastasis of the primary tumor; (5) ECOG score of whole body function status is 0-2 points; (6) Serum albumin ≥30g/L during screening; (7) CRE complicated with late complications such as intestinal obstruction, intestinal fistula, etc., need a first stage resection of the diseased intestine; (8) The subjects and their family members can understand the study protocol and are willing to participate and sign the informed consent.

排除标准：

（1）急诊手术者； （2）术中仅行粘连松解或肠造口而未切除病变肠管者； （3）原发肿瘤不稳定或合并其他部位肿瘤者； （4）需行联合脏器切除者； （5）术后1周后仍需使用肠外营养者。 （6）受试者具有肠内营养禁忌症（例如，活动性胃肠道出血、肠梗阻、失代偿性短肠综合征（有回盲瓣，小肠长度≤100cm，无回盲瓣，小肠长度≤150cm）[30]、高流量肠瘘、重度腹膜内感染、重度胃肠道排空障碍、生命体征不稳定、凝血功能异常、发生重度恶心、呕吐和／或不受控腹泻／脂肪痢），并且上述症状研究者认为无法纠正的；或已知对肠内营养制剂中任何一种药物成分过敏或者较严重的过敏体质者； （7）活动性感染或 严重肝、肾、内分泌、呼吸、神经、心血管疾病； （8）严重精神疾病； （9）怀孕或哺乳期妇女。

Exclusion criteria：

(1) Emergency surgery; (2) Patients who only underwent adhesion release or enterostomy without resection of the diseased bowel; (3) The primary tumor is unstable or combined with tumors at other sites; (4) Patients requiring combined organ resection; (5) Patients who still need to use parenteral nutrition 1 week after surgery. (6) Subjects with contraindications to enteral nutrition (e.g., active gastrointestinal bleeding, intestinal obstruction, decompensated short bowel syndrome (ileocecal valve, small intestine length ≤100cm, no ileocecal valve) Small intestine length ≤150cm) [30], high-flow intestinal fistula, severe intra peritoneal infection, severe gastrointestinal obstruction, unstable vital signs, abnormal coagulation, severe nausea, vomiting, and/or uncontrolled diarrhea/steatorrhea), and the above symptoms are deemed by the investigator to be uncorrected; Or are known to be allergic to any of the pharmaceutical ingredients in enteral nutrition preparations or have a more severe allergy; (7) Active infection or severe liver, kidney, endocrine, respiratory, neurological, cardiovascular diseases; (8) serious mental illness; (9) Pregnant or lactating women.

研究实施时间：

Study execute time：

从 From 2024-08-31 00:00:00至 To 2027-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-08-31 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

干预组、对照组

样本量：

71

Group：

Intervention group and control group

Sample size：

干预措施：

家庭口服营养补充(ONS)+饮食运动常规指导

干预措施代码：

Intervention：

Home oral nutritional supplementation (ONS) +Routine guidance on diet and exercise

Intervention code：

组别：

对照组

样本量：

71

Group：

Control group

Sample size：

干预措施：

饮食运动常规指导

干预措施代码：

Intervention：

Routine guidance on diet and exercise

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guangdong Province 

City：

Guangzhou City 

单位(医院)：

中山大学附属第六医院 

单位级别：

三甲 

Institution
hospital：

The Sixth Affiliated Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

骨骼肌质量指数

指标类型：

主要指标

Outcome：

Skeletal muscle mass index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

握力

指标类型：

次要指标

Outcome：

grip

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

步速

指标类型：

次要指标

Outcome：

Stride speed

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 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）：

利用Excel软件函数RAND()产生编号1-142的随机数，升序排列，前71个为研究组，后71个为对照组。由临床协调员负责产生分配序号，中山大学附属第六医院放射性肠损伤研究团队负责入组受试者，并根据随机序列分配干预措施。

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

The Excel function RAND() was used to generate random numbers numbered 1-142, arranged in ascending order, with the first 71 for the study group and the last 71 for the control group. The clinical coordinator was responsible for generating the assigned serial number, and the radiation intestinal injury research team at the Sixth Affiliated Hospital of Sun Yat-sen University was responsible for enrolling subjects and assigning interventions according to the random sequence.

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：

本研究不设盲。

Blinding：

This study was not blind.

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

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）：

无

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

None

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：

本次试验数据管理采用电子化的科研数据库采集和数据管理。所有资料均应及时、如实、详细地纪录在病历登记表(Case Report Form，CRF)中。病历记录表应由专人填写并经主管教授签名后方能视为有效病例，并将资料录入科研病历数据库。专人对病历记录表(CRF)进行收集和核对和管理。临床试验结束后，需将所有表格归纳、整理，按规范要求写出临床总结报告。

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

The data management of this experiment adopts electronic scientific research database collection and data management. All information should be recorded in a timely, accurate and detailed Case Report Form (CRF). The medical record form should be filled in by a person and signed by the professor in charge before it can be regarded as a valid case, and the data should be entered into the scientific research medical record database. Special personnel collect, check and manage the medical record form (CRF). After the end of the clinical trial, all the forms should be summarized and sorted out, and the clinical summary report should be written according to the standard requirements.

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：

  2024-08-26 16:23:02