ChiCTR2500108583 版本V1.0 版本创建时间2025/09/02 09:18:43 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：

 ChiCTR2500108583 

最近更新日期：

Date of Last Refreshed on：

 2025-09-02 09:18:26 

注册时间：

Date of Registration：

 2025-09-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study

Public title：

Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study

注册题目简写：

Effect of dance-based multimodal exercise for managing CIPN in CRC patients

English Acronym：

Effect of dance-based multimodal exercise for managing CIPN in CRC patients

研究课题的正式科学名称：

Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study

Scientific title：

Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study

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：

Lau Ka Yan 

研究负责人：

Lau Ka Yan 

Applicant：

Lau Ka Yan 

Study leader：

Lau Ka Yan 

申请注册联系人电话：

Applicant telephone：

 +852 3702 4260

研究负责人电话：

Study leader's
telephone：

+852 3702 4260

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：

 1007615222@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1007615222@link.cuhk.edu.hk

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：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究负责人通讯地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Applicant address：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Study leader's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong

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：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Affiliation of the Leader：

The Nethersole School of Nursing, The Chinese University of Hong Kong

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：

 2025.393-T

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：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-31 00:00:00

伦理委员会联系人：

Ms. Amy Li

Contact Name of the ethic committee：

Ms. Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Primary sponsor：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Primary sponsor's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Nethersole School of Nursing, The Chinese University of Hong Kong

具体地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Institution
hospital：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Address：

The Nethersole School of Nursing, The Chinese University of Hong Kong

经费或物资来源：

Not applicable

Source(s) of funding：

Not applicable

研究疾病：

Chemotherapy-induced peripheral neuropathy in colorectal cancer patients  

Target disease：

Chemotherapy-induced peripheral neuropathy in colorectal cancer patients

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：

随机平行对照 

Study design：

Parallel 

研究目的：

To examine the effects of a dance-based multimodal exercise programme when compared to usual care for the management of CIPN in CRC patients across the 3-month post-intervention period. The objectives include (1) To examine the effects of the programme on CIPN (primary outcome) at immediately, one-month and three-month post-intervention; and (2) To examine the effects of the programme on pain, balance, quality of life and anxiety (secondary outcomes) at immediately, one-month and three-month post intervention; and (3) To examine the effects of the programme on knowledge, motivation and self-efficacy of exercise (process outcomes) at immediately, one-month and three-month post intervention; and (4) To assess any adverse effects of the programme; and (5) To explore the perceived benefits, barriers and areas for improvement after participating the programme.  

Objectives of Study：

To examine the effects of a dance-based multimodal exercise programme when compared to usual care for the management of CIPN in CRC patients across the 3-month post-intervention period. The objectives include (1) To examine the effects of the programme on CIPN (primary outcome) at immediately, one-month and three-month post-intervention; and (2) To examine the effects of the programme on pain, balance, quality of life and anxiety (secondary outcomes) at immediately, one-month and three-month post intervention; and (3) To examine the effects of the programme on knowledge, motivation and self-efficacy of exercise (process outcomes) at immediately, one-month and three-month post intervention; and (4) To assess any adverse effects of the programme; and (5) To explore the perceived benefits, barriers and areas for improvement after participating the programme.

药物成份或治疗方案详述：

Not applicable 

Description for medicine or protocol of treatment in detail：

Not applicable 

纳入标准：

The inclusion criteria of participants include CRC patients who (1) have received or currently receiving more than one cycle of oxaliplatin-based chemotherapy; and (2) experience CIPN symptoms; and (3) are able to use smart phone and WhatsApp; and (4) are able to read or understand Chinese.

Inclusion criteria

The inclusion criteria of participants include CRC patients who (1) have received or currently receiving more than one cycle of oxaliplatin-based chemotherapy; and (2) experience CIPN symptoms; and (3) are able to use smart phone and WhatsApp; and (4) are able to read or understand Chinese.

排除标准：

CRC patients will be excluded from this study when they (1) received neurotoxic chemotherapy other than oxaliplatin, including taxane-based chemotherapy, vinca alkaloids, proteasome inhibitors and thalidomide analogs; or (2) suffer from severe organ failure or diseases that limit their level of activity; or (3) are diagnosed with non-chemotherapy induced peripheral neuropathy, such as sciatica and diabetic neuropathy; or (4) receive treatments that affect the severity of neuropathy, such as steroid, anticonvulsants and antidepressants; or (5) age below 18 years old; or (6) have cognitive impairments.

Exclusion criteria：

CRC patients will be excluded from this study when they (1) received neurotoxic chemotherapy other than oxaliplatin, including taxane-based chemotherapy, vinca alkaloids, proteasome inhibitors and thalidomide analogs; or (2) suffer from severe organ failure or diseases that limit their level of activity; or (3) are diagnosed with non-chemotherapy induced peripheral neuropathy, such as sciatica and diabetic neuropathy; or (4) receive treatments that affect the severity of neuropathy, such as steroid, anticonvulsants and antidepressants; or (5) age below 18 years old; or (6) have cognitive impairments.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-15 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：

Dance-based multimodal exercise programme

样本量：

 42

Group：

Dance-based multimodal exercise programme

Sample size：

干预措施：

This study adopts the components in Information-Motivation-Behavioral Skills (IMB) model in a dance-based multimodal exercise program, which integrates the dance-components in a multimodal exercise program. Zumba Gold dance which encompasses endurance, resistance, balance and flexibility training will be adopted in this study. Before the intervention, participants will be asked to set exercise goals. It is a six-weekly Zumba Gold dance carried out in the community cancer centers, including Cancer Information Charity Foundation, Jockey Club of Institute Cancer Care, and Christian Family Service Centre. Each dance group consists of five to ten participants. In total, there are six face-to-face dance sessions. Each session lasts for 75 minutes. The 75-minute class will be structured as follows: approximately ten minutes dedicated to vital sign measurement and revision of previously learned skills, followed by a 50-minute multimodal exercise session that includes warm-up, workout, and cool-down exercises based on the Zumba Gold manual (Zumba Fitness, 2011), and concluding with a 15-minute sharing session. A study by Zimmer et al. (2018) demonstrated that a similar 50-minute multimodal exercise program was well-tolerated among patients with advanced colorectal cancer (CRC). After each session, videos of dance skills will be sent to participants for the revision via Whatsapp. Participants will be encouraged to do self-practice at home. Safety precautions about self-practice are included in the videos. Participants will learn all dance skills, including warm-up dance, Merengue, Salsa, Cumbia, Belly dance, Flamenco, Tango and cool-down dance in first four sessions, followed by two revision sessions of all dance skills in fifth and sixth sessions. Participants with balance problems (baseline Time up-to-go test > ten seconds) or physical limitations are advised to have chair dance, which upper limb movements are the same as the usual Zumba Gold dance. Motivational and support sessions in 10th week and 14th week will be provided through the evaluation of the goal and encouragement messages via whatsapp. An oncology nurse, who has at least three-year clinical oncology experience and receive Zumba Gold training, will provide the tele-support to participants about the enquiry about the dance techniques and the symptom management related to the CIPN via Whatsapp to promote self-efficacy in managing CIPN by dance. Participants may send messages to the oncology nurse at anytime. The oncology nurse will check the message at 6pm everyday and reply all the messages at 6-8pm everyday.

干预措施代码：

Intervention：

This study adopts the components in Information-Motivation-Behavioral Skills (IMB) model in a dance-based multimodal exercise program, which integrates the dance-components in a multimodal exercise program. Zumba Gold dance which encompasses endurance, resistance, balance and flexibility training will be adopted in this study. Before the intervention, participants will be asked to set exercise goals. It is a six-weekly Zumba Gold dance carried out in the community cancer centers, including Cancer Information Charity Foundation, Jockey Club of Institute Cancer Care, and Christian Family Service Centre. Each dance group consists of five to ten participants. In total, there are six face-to-face dance sessions. Each session lasts for 75 minutes. The 75-minute class will be structured as follows: approximately ten minutes dedicated to vital sign measurement and revision of previously learned skills, followed by a 50-minute multimodal exercise session that includes warm-up, workout, and cool-down exercises based on the Zumba Gold manual (Zumba Fitness, 2011), and concluding with a 15-minute sharing session. A study by Zimmer et al. (2018) demonstrated that a similar 50-minute multimodal exercise program was well-tolerated among patients with advanced colorectal cancer (CRC). After each session, videos of dance skills will be sent to participants for the revision via Whatsapp. Participants will be encouraged to do self-practice at home. Safety precautions about self-practice are included in the videos. Participants will learn all dance skills, including warm-up dance, Merengue, Salsa, Cumbia, Belly dance, Flamenco, Tango and cool-down dance in first four sessions, followed by two revision sessions of all dance skills in fifth and sixth sessions. Participants with balance problems (baseline Time up-to-go test > ten seconds) or physical limitations are advised to have chair dance, which upper limb movements are the same as the usual Zumba Gold dance. Motivational and support sessions in 10th week and 14th week will be provided through the evaluation of the goal and encouragement messages via whatsapp. An oncology nurse, who has at least three-year clinical oncology experience and receive Zumba Gold training, will provide the tele-support to participants about the enquiry about the dance techniques and the symptom management related to the CIPN via Whatsapp to promote self-efficacy in managing CIPN by dance. Participants may send messages to the oncology nurse at anytime. The oncology nurse will check the message at 6pm everyday and reply all the messages at 6-8pm everyday.

Intervention code：

组别：

Control group

样本量：

 43

Group：

Control group

Sample size：

干预措施：

After receiving the educational booklet and logbook, weekly Whatsapp message with videos of exercises recommended for elderly by Department of Health, HKSAR (Elderly Health Service, 2025) will be provided for participants in control group in the first six weeks. Participants are encouraged to follow the NCCN and ACSM guidelines for cancer survivors to enhance their health and well-being through exercise. These recommendations include engaging in at least 150 minutes of moderate-intensity activity each week or alternatively, performing 75 minutes of vigorous-intensity exercise, or a combination of both. Each exercise session should begin with a light-intensity aerobic warm-up and stretching, with stretching exercises included on at least two non-resistance training days. Additionally, resistance training should be performed 2 to 3 times per week, consisting of 2 to 3 sets of 10 to 15 repetitions per exercise, with rest intervals of 2 to 3 minutes between sets. For survivors experiencing chemotherapy-induced peripheral neuropathy (CIPN), balance training is particularly important. Those with neuropathy and balance issues may benefit from alternative exercises, such as stationary cycling and water exercises, if walking is not feasible. Encouragement messages will be sent in 10th and 14th week.

干预措施代码：

Intervention：

After receiving the educational booklet and logbook, weekly Whatsapp message with videos of exercises recommended for elderly by Department of Health, HKSAR (Elderly Health Service, 2025) will be provided for participants in control group in the first six weeks. Participants are encouraged to follow the NCCN and ACSM guidelines for cancer survivors to enhance their health and well-being through exercise. These recommendations include engaging in at least 150 minutes of moderate-intensity activity each week or alternatively, performing 75 minutes of vigorous-intensity exercise, or a combination of both. Each exercise session should begin with a light-intensity aerobic warm-up and stretching, with stretching exercises included on at least two non-resistance training days. Additionally, resistance training should be performed 2 to 3 times per week, consisting of 2 to 3 sets of 10 to 15 repetitions per exercise, with rest intervals of 2 to 3 minutes between sets. For survivors experiencing chemotherapy-induced peripheral neuropathy (CIPN), balance training is particularly important. Those with neuropathy and balance issues may benefit from alternative exercises, such as stationary cycling and water exercises, if walking is not feasible. Encouragement messages will be sent in 10th and 14th week.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Community Cancer Centers 

单位级别：

 Community Health Service Center 

Institution
hospital：

Community Cancer Centers

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

Chemotherapy-induced peripheral neuropathy 5:19 PM

指标类型：

主要指标

Outcome：

Chemotherapy-induced peripheral neuropathy 5:19 PM

Type：

Primary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx)

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale (FACT/GOG-Ntx)

指标中文名：

Pain

指标类型：

次要指标

Outcome：

Pain

Type：

Secondary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

Douleur Neuropathique en 4 Questions (DN-4)

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

Douleur Neuropathique en 4 Questions (DN-4)

指标中文名：

Quality of Life

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ C30)

指标中文名：

Anxiety

指标类型：

次要指标

Outcome：

Anxiety

Type：

Secondary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

Hospital Anxiety and Depression Scale (HADS)

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

Hospital Anxiety and Depression Scale (HADS)

指标中文名：

Balance

指标类型：

次要指标

Outcome：

Balance

Type：

Secondary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

Time up-to-go

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

Time up-to-go

指标中文名：

Knowledge of exercise, exercise motivation and exercise self-efficacy

指标类型：

次要指标

Outcome：

Knowledge of exercise, exercise motivation and exercise self-efficacy

Type：

Secondary indicator

测量时间点：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

Perceived Physical Literacy Instrument (PPLI)

Measure time point of outcome：

Baseline, 6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

Perceived Physical Literacy Instrument (PPLI)

指标中文名：

Process evaluation

指标类型：

附加指标

Outcome：

Process evaluation

Type：

Additional indicator

测量时间点：

18th week (3-month post intervention)

测量方法：

focus-group interview

Measure time point of outcome：

18th week (3-month post intervention)

Measure method：

focus-group interview

指标中文名：

Adverse effects

指标类型：

次要指标

Outcome：

Adverse effects

Type：

Secondary indicator

测量时间点：

6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

测量方法：

self-report

Measure time point of outcome：

6th week (immediately post-intervention), 10th week (one-month post intervention) and 18th week (three-month post intervention)

Measure method：

self-report

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 NA 岁 years
最大 Max age NA 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）：

CRC patients who are fulfilling the eligibility criteria and willing to participate in the programme will be randomized in 1:1 ratio after the baseline measurement. A computer-generated randomization list in a block of four is generated before the randomization. Allocation numbers are concealed in opaque sealed envelopes which only the principal investigator will open them and inform the participants about the program details.

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

CRC patients who are fulfilling the eligibility criteria and willing to participate in the programme will be randomized in 1:1 ratio after the baseline measurement. A computer-generated randomization list in a block of four is generated before the randomization. Allocation numbers are concealed in opaque sealed envelopes which only the principal investigator will open them and inform the participants about the program details.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

An independent assessor will be blinded for the allocation of the participants and intervention.

Blinding：

An independent assessor will be blinded for the allocation of the participants and intervention.

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）：

NA

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

NA

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：

Self-reported measures

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

Self-reported measures

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-09-02 09:18:26