【ChiCTR2600119373】The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

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基本信息

登记号

ChiCTR2600119373

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

2026-02-26

临床申请受理号

靶点

适应症

Colorectal cancer

试验通俗题目

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

试验专业题目

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

申办单位信息

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临床试验信息

试验目的

The objective of this study is to examine the feasibility and preliminary efficacy of a 12-week Tai Chi intervention in improving gut microbiota diversity among patients with colorectal cancer at 12-week and 24-week follow-ups compared with a self-managed control group.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

The random number sequence will be generated by an independent biostatistician using computer-generated block randomization with randomly varied block sizes between 6 and 12, stratified by primary cancer treatment (targeted therapy versus non-targeted therapy). The allocation sequence will be maintained by the biostatistician and will not be accessible to the research team members involved in participant recruitment or assessment to ensure allocation concealment.

盲法

All research team members, except for the research assistant responsible for informing participants of their group allocation, will be blinded to group assignment. Outcome assessments will be conducted by research assistants who are blinded to allocation. Tai Chi instructors will not be informed of the study design and will not be involved in outcome assessment. Due to the nature of the behavioral intervention, participants cannot be blinded.

试验项目经费来源

Not applicable

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-03-01

试验终止时间

2027-12-31

是否属于一致性

入选标准

1. Diagnosed with colorectal cancer confirmed by pathology, with no other cancer diagnosis within the previous year. 2. Karnofsky Performance Status (KPS) score >=70. 3. Aged 18 years or above. 4. Able to communicate in Cantonese or Mandarin. 5. Conscious and alert.；

排除标准

1. Somatic conditions that limit participation in exercise (e.g., limb loss, severe balance or postural instability, serious cardiopulmonary limitation, neurological or sensory deficits). 2. Current participation in any behavioral trial or instructor-led exercise program. 3. Regular practice of physical activity defined as >=150 minutes of moderate-intensity physical activity per week.；

研究者信息

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试验机构

The Hong Kong Polytechnic University

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