Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

注册号:

Registration number:

ITMCTR2025000199

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺治疗晚期癌症相关失眠:随机对照试验的试点研究

Public title:

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

注册题目简写:

针刺治疗晚期癌症相关失眠:随机对照试验的试点研究

English Acronym:

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

研究课题的正式科学名称:

针刺治疗晚期癌症相关失眠:随机对照试验的试点研究

Scientific title:

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled trial

研究课题的正式科学名称简写:

针刺治疗晚期癌症相关失眠:随机对照试验的试点研究

Scientific title acronym:

Acupuncture for advanced cancer-related insomnia: a pilot study of a randomized controlled 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:

郭子宁

研究负责人:

崔韶阳

Applicant:

Zining Guo

Study leader:

Shaoyang Cui

申请注册联系人电话:

Applicant telephone:

13266233271

研究负责人电话:

Study leader's telephone:

15112491899

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:

20232110092@stu.gzucm.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

herb107@126.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:

广州中医药大学深圳医院(福田)

研究负责人通讯地址:

广州中医药大学深圳医院(福田)

Applicant address:

Shenzhen Hospital (Fu Tian) of Guangzhou University of Chinese Medicine

Study leader's address:

Shenzhen Hospital (Fu Tian) of Guangzhou University of Chinese Medicine

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:

广州中医药大学深圳医院(福田)

Applicant's institution:

Shenzhen Hospital (Fu Tian) of Guangzhou 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:

GZYLL(KY)-2024-031

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:

广州中医药大学深圳医院(福田)医学伦理委员会

Name of the ethic committee:

Shenzhen Hospital (Fu Tian) of Guangzhou University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/9/12 0:00:00

伦理委员会联系人:

卢琳

Contact Name of the ethic committee:

0755-83458506

伦理委员会联系地址:

广东省深圳市广州中医药大学深圳医院(福田)

Contact Address of the ethic committee:

Shenzhen Hospital of Guangzhou University of Traditional Chinese Medicine (Futian) Shenzhen Guangdong Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

0755-83458506

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gzyszyyll@126.com

研究实施负责(组长)单位:

广州中医药大学深圳医院(福田)康复科

Primary sponsor:

Department of Rehabilitation Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital (Futian)

研究实施负责(组长)单位地址:

广州中医药大学深圳医院(福田)康复科

Primary sponsor's address:

Department of Rehabilitation Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital (Futian)

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):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

广州中医药大学深圳医院(福田)

具体地址:

广东省深圳市福田区广州中医药大学深圳医院(福田)

Institution
hospital:

Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian)

Address:

Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital (Futian) Futian District Shenzhen Guangdong Province China

经费或物资来源:

深圳市三名工程

Source(s) of funding:

SZSM201502044

研究疾病:

癌症

研究疾病代码:

Target disease:

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

在晚期癌症患者接受系统性抗癌治疗的背景下,初步明确针刺治疗晚期癌症相关失眠的疗效以及通过缓解失眠症状是否能够改善伴随相关症状,以提高患者的生活质量。此外,选取单项失眠印象评分作为锚点,使用锚定法评估出响应人群的最小临床差异为下一步大型随机对照试验提供参考。同时,运用静息态功能磁共振挖掘针刺发挥疗效的“脑网络”机制。对预先规定招募率和脱落率进行评估、观察受试者依从性、盲法的成功率。通过上述旨在初步明确针刺的疗效、潜在机制及确定方案可行性。

Objectives of Study:

Under the multidisciplinary team approach the type of advanced cancer is delineated and systemic palliative care is used as the basic treatment.Under the concept of "patient-centeredness" outcome indicators were chosen from different perspectives centered on the ISI and combined with the rest of the subjective assessment tools comparing acupuncture with sham acupuncture aiming at determining the efficacy of acupuncture in insomnia associated with advanced cancer as well as evaluating the degree of co-morbidities relief.In the current study appropriate anchor points will be selected and the MCID of the responding population will be assessed using the anchoring method. at the same time the rs-fMRI technique will be utilized to excavate the mechanism by which acupuncture exerts its therapeutic effect which will provide reference information for the subsequent large-scale RCT.

药物成份或治疗方案详述:

我们根据国际中医药工作所推荐用于针刺治疗癌症症状的共4周的周期作为本次的研究总周期。两组患者均为每2日治疗一次,一周治疗3次,持续4周,共治疗12次。每次治疗留针30min,在留针期间,针刺组每10min行针一次,每根针手动行针 10 秒,共行针3次:假针刺组每10min触碰针身一次,不行针刺手法刺激,共触碰3次。两组患者均给予基础治疗:①所有纳入病例根据表现状态(PS)进行系统性一线/二线姑息全身抗癌维持治疗包括化疗、靶向、免疫治疗、联合治疗等。由临床医师与治疗师参照美国国立综合癌症网络《NCCN Clinical Practice Guidelines in Oncology NCCN Guidelines®》以及中国临床肿瘤学会 (Chinese Society of Clinical Oncology,简称CSCO)制定相关指南给予基础系统性姑息全身抗癌的维持治疗。其他方面,根据患者的病情与症状制定包括但不局限于抗凝治疗、抗聚治疗、控制危险因素及康复护理等治疗的计划并实施相关治疗,不给予中药治疗。

Description for medicine or protocol of treatment in detail:

We used a total of 4 weeks as the total period of this study based on the cycle of a total of 4 weeks recommended by the International Work on Traditional Chinese Medicine (IWTCM) for the treatment of cancer symptoms with acupuncture.Both groups of patients were treated once every 2 days 3 times a week for 4 weeks for a total of 12 treatments.During each treatment needles were left for 30 min and during the period of needle retention the needles in the needling group were performed once every 10 min and each needle was manually performed for 10 seconds for a total of 3 times: in the sham-needling group the body of the needles was touched once every 10 min and it was not possible to stimulate the needles with needling maneuvers and the body of the needles was touched for a total of 3 times.Both groups were given basic treatment:①All the included cases were treated with systemic first-line/second-line palliative systemic anticancer maintenance therapy including chemotherapy targeted immunotherapy and combination therapy according to the performance status (PS).Clinicians and therapists should refer to the NCCN Clinical Practice Guidelines in Oncology NCCN Guidelines® and the Chinese Society of Clinical Oncology (CSCO) guidelines for basic systemic palliative care.The Chinese Society of Clinical Oncology (CSCO) and the National Comprehensive Cancer Network (NCCN) Guidelines in Oncology (NCCN Guidelines®) have been developed to provide basic systemic palliative systemic anti-cancer maintenance therapy.In other aspects according to the patient's condition and symptoms a treatment plan including but not limited to anticoagulation therapy antipolymerization therapy control of risk factors and rehabilitation care will be formulated and implemented and no traditional Chinese medicine treatment will be given.

纳入标准:

(1)符合精神障碍诊断标准第五版以及所规定的晚期癌症诊断标准 (2)年龄18-75岁; (3)东部肿瘤合作组 (ECOG)体能状态 ≤ 2 分; (4)睡眠严重程度指数量表 (ISI) 评分 ≥ 8分; (5)根据PaP评分活动状态≥ 60分结合临床医生判断预计生存时间≥ 6 月; (6)目前预计接受或正接受系统性姑息全身抗癌治疗,包括化疗、免疫治疗或联合治疗等; (7)既往 6 个月未接受针灸治疗; (8)意识清楚,生命体征平稳,无明显沟通障碍治疗; (9)了解试验并签署知情同意书; (10)目前服用稳定剂量的镇静催眠药物的受试者可纳入(稳定剂量定义为在研究开始前6周内没有改变药物类型或剂量)

Inclusion criteria

(1) Meet the fifth edition of the Diagnostic Criteria for Mental Disorders and the defined diagnostic criteria for advanced cancer (2) Age 18-75 years; (3) Eastern Cooperative Oncology Group (ECOG) physical status ≤ 2 points; (4) Sleep Severity Index Scale (ISI) score ≥ 8. (5) Expected survival time ≥ 6 months based on PaP score activity status ≥ 60 points combined with clinician judgment; and (6) Currently expect to receive or are receiving systemic palliative systemic anticancer therapy including chemotherapy immunotherapy or combination therapy; (7) Previously expect to receive or are receiving systemic palliative systemic anticancer therapy including chemotherapy immunotherapy or combination therapy. (7) Have not received acupuncture treatment in the previous 6 months; and (8) be conscious have stable vital signs and have no obvious communication disorders to treat; and (9) Understanding of the trial and signing an informed consent form. (10) Subjects currently taking a stable dose of sedative-hypnotic medication were eligible for inclusion (stable dose was defined as no change in the type or dose of medication within 6 weeks prior to the start of the study)

排除标准:

(1)不可纠正的弥漫性血管内凝血或严重血小板减少伴有出血倾向,即血小板计数<15,000/µL;国际标准化比值(INR)>1.5;血红蛋白≤90g/dL ; (2)手术治疗、转化治疗、根治性放疗等接受以根治为目的治疗患者; (3)针灸禁忌症,如针刺部位的溃疡、脓肿、皮肤感染等; (4)合并有严重循环系统、呼吸系统、消化系统、泌尿系统、内分泌系统和造血系统等原发性疾病且常规用药无法控制的患者; (5)癌症疼痛引起的失眠,且数字评定量表(NRS)评分≥4,或其他躯体疾病引起的失眠; (6)近 3 个月曾接受除催眠药物外其他失眠治疗 (7)近 3 个月内参加过其他临床医学试验研究; (8)曾有精神疾病史或正在接受精神障碍治疗的患者; (9)脑部肿瘤或以广泛转移至脑部患者; (10)孕妇或哺乳期女性; (11)其他睡眠障碍的类型:不宁腿综合征、睡眠觉醒障碍; 幽闭恐惧症或符合功能性磁共振其他禁忌症;

Exclusion criteria:

(1) Uncorrectable diffuse intravascular coagulation or severe thrombocytopenia with bleeding tendency i.e. platelet count <15000/µL; International Normalized Ratio (INR) >1.5; hemoglobin ≤90 g/dL ;and (2) Surgical treatment conversion therapy radical radiotherapy and other patients receiving treatment aimed at eradication; (3) Contraindications to acupuncture such as ulcers abscesses and skin infections at the site of needling; and (4) Patients who have a combination of serious circulatory respiratory digestive urinary endocrine and hematopoietic systems and other primary diseases that cannot be controlled by conventional medication; and (5) Insomnia caused by cancer pain with Numerical Rating Scale (NRS) score ≥4 or insomnia caused by other somatic diseases; and (6) Treatment for insomnia other than hypnotic drugs in the last 3 months (7) have participated in other clinical medical trial studies in the last 3 months; and (8) Patients with a history of mental illness or being treated for mental disorders; and (9) Patients with brain tumors or with extensive metastases to the brain; (10) Pregnant or lactating women; and (11) Other types of sleep disorders: restless legs syndrome sleep-wake disorders. claustrophobia or other contraindications to functional magnetic resonance; and

研究实施时间:

Study execute time:

From 2024-09-12

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2025-01-31

To      2025-12-31

干预措施:

Interventions:

组别:

假针刺组

样本量:

30

Group:

Sham acupuncture

Sample size:

干预措施:

假针刺

干预措施代码:

Intervention:

Sham acupuncture

Intervention code:

组别:

针刺组

样本量:

30

Group:

Acupuncture

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

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):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

广州中医药大学深圳医院(福田)

单位级别:

三甲

Institution/hospital:

Shenzhen hospital (Fu tian) of Guangzhou University of Chinese Medicine

Level of the institution:

top three

测量指标:

Outcomes:

指标中文名:

欧洲癌症研究与治疗组织生活质量问卷30项

指标类型:

次要指标

Outcome:

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 items

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单项患者总体印象-失眠严重程度

指标类型:

次要指标

Outcome:

Single Patient Overall Impression - Insomnia Severity

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静息态功能性磁共振

指标类型:

附加指标

Outcome:

Resting-state functional magnetic resonance

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

埃德蒙顿症状评估量表

指标类型:

次要指标

Outcome:

Edmonton symptom assessment scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠指数

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失眠严重指数

指标类型:

主要指标

Outcome:

Insomnia Severity Index

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:

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

代谢组学

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机分配采用中央随机系统分层区组随机的方法。根据不同中心进行分层,区组为4个模块。系统会自动分配患者并将分组结果返回给研究者。将纳入患者随机分为针刺组、假针刺组。分配信息在受试者纳入前是不可预测且不可见的,确保了分配序列的隐藏和随机化过程的公平性。随机分配系统研发及执行由广州中医药大学临床研究与数据中心人员(与试验无关第三方成员)完成。分配隐藏机制及实施:当研究者确认合格病例之后,向中央随机系统提出申请,中央随机系统自动分配组别信息,并将受试者分配干预措施的信息发送回研究者。

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

Random assignment was done using the Central Randomization System (CRS) stratified block group randomization.Stratification is based on different centers and the zonal groups are 4 modules.The system automatically assigns patients and returns the grouping results to the investigator.The included patients were randomized into the acupuncture group and the sham acupuncture group.The allocation information is unpredictable and invisible until the subjects are included ensuring that the allocation sequence is hidden and the randomization process is fair.The development and implementation of the random allocation system was done by the staff of the Clinical Research and Data Center of Guangzhou University of Traditional Chinese Medicine (a third-party member unrelated to the trial).Allocation concealment mechanism and implementation:After the investigator confirms the eligible cases he/she submits a request to the central randomization system which automatically allocates group information and sends the information about the subject's allocation to the intervention back to the investigator.

盲法:

本研究采用主要研究者盲法,即研究设计者、受试者、结局评估者和统计分析者对分组情况不知情,针灸师不设盲。针刺盲法辅助装置采用广州中医药大学附属第一医院的装置且已在多项研究被证明有效。该装置已获得国家知识产权局专利(授权号:202121352221.7)。该针刺盲法辅助装置由底座、导管、粘胶贴构成。底座由树脂材料制成,不透明,可以阻挡受试者的视线,使受试者无法从视觉上辨别针是否已经穿透皮肤。底座内部中空,表面则配有三个孔,一个在顶部,为直刺孔,用于直刺;两个在侧面,一个位置略高,为斜刺孔,用于斜刺;一个位置略低,为平刺孔,用于平刺。底座的底部装有3M牌粘胶贴,用于确保底座能牢牢的固定在穴位处的皮肤上。粘胶贴表面覆盖有一层塑料膜,在使用时可揭下露出粘胶贴。导管则由透明塑料制成,便于针灸医师通过导管插入毫针。该针刺盲法辅助装置有两种类型:A型和B型。两种类型的底座装置形状相同,但A型针刺盲法辅助装置底部是中空的粘胶贴,允许毫针直接地插入皮肤,用于真针刺。B型的底部则是实心的粘胶贴,使用一次性钝头针无法刺破表皮。实心粘胶贴能将假针牢牢固定在适当位置,防止其上下移动。

Blinding:

This study was conducted with principal investigator blinding i.e. the study designer subjects outcome assessors and statistical analysts were unaware of the subgroups and the acupuncturists were not blinded.The acupuncture blinding aid was a device from the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine that has been shown to be effective in several studies.The device has been patented by the State Intellectual Property Office (Grant No. 202121352221.7).The acupuncture blindness assisting device consists of a base a catheter and an adhesive sticker.The base is made of a resin material that is opaque and blocks the subject's vision so that the subject cannot visually discern whether the needle has penetrated the skin.The interior of the base is hollow and the surface is equipped with three holes one at the top for straight stabbing holes for straight stabbing; two on the side one position is slightly higher for oblique stabbing holes for oblique stabbing; one position is slightly lower for flat stabbing holes for flat stabbing.The bottom of the base is equipped with a 3M adhesive sticker to ensure that the base can be firmly fixed on the skin at the acupuncture points.The adhesive tape is covered with a plastic film that can be removed to reveal the adhesive tape during use.The catheter is made of transparent plastic making it easy for the acupuncturist to insert the needle through the catheter.There are two types of these blind needling aids: Type A and Type B. The base unit is identical in shape to the base unit.Both types have the same shape but Type A has a hollow adhesive base that allows the needles to be inserted directly into the skin for true needling while Type B has a solid adhesive base that does not allow disposable blunt-tipped needles to pierce the epidermis.The solid adhesive patch holds the dummy needle firmly in place and prevents it from moving up or down.

是否共享原始数据:

IPD sharing:

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):

联系研究负责人

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

Contact the Head of Research

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:

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)。本研究所有数据保存均由广州中医药大学深圳医院康复科联合白塔数据构建专病数据库中电子CRF模块进行保存,所有产生的数据将由两名独立数据录入员进行录入(见图10)。在数据录入正式开始前,对数据录入员进行SOP专门的培训。当数据录入完毕后,将由专门的数据检查人员对数据进行逐一核查,将不正确的数据进行重新录入。 此外,本临床研究所收集纸质的知情同意书、所有受试者的CRF表,及其他相关数据档均存纸质资料妥善保存在广州中医药深圳医院康复科GCP档案室中。

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

Data collection and management consists of two parts Case Record Form (CRF) and Electronic Data Capture (EDC).All the data saved in this study were saved by the Department of Rehabilitation of Guangzhou University of Traditional Chinese Medicine Shenzhen Hospital in conjunction with White Tower Data to construct the electronic CRF module in the specialized disease database and all the data generated will be entered by two independent data entry clerks (see Figure 10).Before the official start of data entry the data entry clerks will be specifically trained in SOP.When data entry is complete the data will be checked individually by specialized data checkers and incorrect data will be re-entered. In addition paper informed consent forms CRF forms of all subjects and other related data files were collected and stored in paper form in the GCP archive room of the Department of Rehabilitation Guangzhou Hospital of Traditional Chinese Medicine Shenzhen China.

数据管理委员会:

Data Managemen Committee:

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