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【ChiCTR2500108583】Effects of dance-based multimodal exercise programme for managing chemotherapy-induced peripheral neuropathy in patients with colorectal cancer: A randomized controlled study

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基本信息

登记号

ChiCTR2500108583

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-09-02

临床申请受理号

靶点

适应症

Chemotherapy-induced peripheral neuropathy in colorectal cancer patients

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

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.

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

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.

盲法

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

试验项目经费来源

Not applicable

试验范围

目标入组人数

42;43

实际入组人数

第一例入组时间

2025-09-01

试验终止时间

2026-08-31

是否属于一致性

入选标准

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.；

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.；

研究者信息

研究负责人姓名

试验机构

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

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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