2014年7月5日 星期六
hkugrant110878: A randomized, controlled trial of the efficacy of Guolin-Qigong on body-mind health of Chinese women with breast cancer
Grant: A randomized, controlled trial of the efficacy of Guolin ...
hub.hku.hk/cris/project/hkugrant110878
Grant: A randomized, controlled trial of the efficacy of Guolin-Qigong on body-mind health of Chinese women with breast cancer ...
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中国临床试验注册中心简介
中国临床试验注册中心（Chinese Clinical Trial Registry, ChiCTR）是由卫生部指定代表我国参加世界卫生组织国际临床试验注册平台的国家临床试验注册中心，是世界卫生组织国际临床试验注册平台的一级注册机构，签署《渥太华工作组关于临床试验注册的声明》(Ottawa Group Statement for Clinical Trial Registration)，是一个非赢利的学术机构，位于四川大学华西医院。
中国临床试验注册中心的注册程序和内容完全符合WHO国际临床试验注册平台（WHO ICTRP）和国际医学期刊编辑委员会（ICMJE）的标准。
中国临床试验注册中心接受在中国和全世界实施的临床试验注册，公布研究设计信息、国际统一注册号的接口、审核研究设计、中心随机分配以保障注册临床试验的质量。
A randomized, controlled trial of the efficacy of TCM exercise on body-mind health of Chinese women with breast cancer
Registration number：
ChiCTR-TRC-14004290
Date of releasing the registration number：
2014/02/24
Registration Status：
Retrospective registration
Public title：
A randomized, controlled trial of the efficacy of TCM exercise on body-mind health of Chinese women with breast cancer
Scientific title：
A randomized, controlled trial of the efficacy of TCM exercise on body-mind health of Chinese women with breast cancer
Secondary ID：
Applicant：
You Jieshu
Study leader：
Chen Jianping
Applicant telephone：
+852 64381324
Study leader's telephone：
+86 85225890479
Applicant Fax：
Study leader's fax：
Applicant E-mail：
youyaling@163.com
Study leader's E-mail：
abchen@hku.hk
Applicant website(voluntary supply)：
Study leader's website(voluntary supply)：
Applicant address：
1/F, Sassoon Road No. 10, School of Chinese Medicine, the Universitiy of Hong Kong
Study leader's address：
Sassoon Road No. 10, School of Chinese Medicine, the Universitiy of Hong Kong
Applicant postcode：
Study leader's postcode：
Applicant's institution：
School of Chinese Medicine, the University of Hong Kong
Approved by ethic committee：
Yes
Approved No. of ethic committee：
UW 12-046
Approved file of Ethical Committee：
查看附件View
Name of the ethic committee：
Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)
Date of approved by ethic committee：
2013/10/11
Primary sponsor：
The university of Hong Kong
Primary sponsor's address：
The University of Hong Kong, Pokfulam, Hong Kong
Secondary sponsor：
Country：
China
Province：
Hong Kong
City：
Institution
hospital：
Faculty of Medicine, HKU
Address：
Source(s) of funding：
Health and Medical Research Fund
Target disease：
breast cancer
Target disease code：
Study type：
Interventional
Study phase：
Phase I
Objectives of Study：
1) To determine the effectiveness of GLQG in improving physical fitness, Qol and psychological well-being of cancer patients using Meta-analysis; 2) To examine the efficacy of GLQG in improving physical fitness, Qol and psychological well-being outcomes using the Functional Assessment of Breast Cancer Treatment version-3-scale (FACT-B (Ch)) and the Hospital Anxiety and Depression Scale (HADS) respectively among breast cancer patients against a control group that received only health information but no GLQG intervention; 3) To examine the efficacy of GLQG in enhancing the immune function through detecting the levels of serum NK and IL-6 among breast cancer patients against the control group; and to examine the effect of GLQG on the development of cancer cells through detecting the level of serum cancer-related indices including CA15-3 and CEA of breast cancer patients against the control group; 4) To examine the effect of exercising duration on the efficacy of GLQG on breast cancer patients.
Study design：
Randomized parallel control
Inclusion criteria
(1) female with a histological diagnosis of primary breast cancer stage 0- IIIb, aged 21 or above; (2) be between 1 month and 3 years after surgery and having no drainage tubes or catheters; (3) not engaging in exercising Qigong in the past one year; (4) having no clinical diagnoses of severe mental disorders or history of psychiatric illness.
Exclusion criteria：
(1) taking psychotropic drugs; (2) any medical conditions that limit their body movement; (3) having serious concomitant disease or other cancers. Eligible patients will be invited to participate in this study and informed written consent will be achieved from all participants.
Study execute time：
From2013-10-10To
Interventions：
79
Group：
GLQG group
Sample size：
Intervention：
Guo Lin Qi Gong
Intervention code：
79
Group：
control group
Sample size：
Intervention：
Western exercise
Intervention code：
Countries of recruitment and research settings：
Country：
China
Province：
Hong Kong
City：
Institution
hospital：
Faculty of Medicine, HKU
Level of the institution：
Country：
China
Province：
Hong Kong
City：
Institution
hospital：
Queen Mary Hospital
Level of the institution：
Outcomes：
Outcome：
Quality of life
Outcome：
Anxiety and depression
Outcome：
interleukin-6 (IL-6) and NK cell activity (NKCA)
Collecting sample(s)
from participants：
Sample Name：
Blood
Tissue：
Fate of sample：
Destruction after use
Note：
Recruiting status：
Recruiting
Participant age：
Min age 18 years
Max age 70 years
Randomization Procedure (please state who generates the random number sequence and by what method)：
he block randomization method
Gender：
Female
Blinding：
Calculated Results ater
the Study Completed：
Organizer institution (leader institution)：
Data collection Institution：
Data management Institution：
Data analysis Institution：
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临床试验公共管理平台 Clinical Trial Management Public Platform 中国注册临床试验伦理审查委员会 chinese ethics committee of registering clinical trials 医学期刊出版与编辑伦理网 Medical Journal Publication and Edite Ethics Network 欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong Ottawa Statement on Trial Registration
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