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Trial registered on ANZCTR


Registration number
ACTRN12613000211763
Ethics application status
Approved
Date submitted
5/02/2013
Date registered
21/02/2013
Date last updated
21/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Platform establishment of integrative Chinese-Western medical treatment for cancer patients
Scientific title
Using an integrative Chinese-Western medical treatment for cancer patients to evaluate the clinical efficacy.
Secondary ID [1] 281882 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 288275 0
Condition category
Condition code
Cancer 288625 288625 0 0
Any cancer
Public Health 288679 288679 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cancer patients are diagnosed by Western medicine doctors for pathology report, cancer-related catastrophic illness from health insurance information, and International Classification of Diseases 9th code (ICD-9 code). Patients use western medicine which includes Tamoxifen (Tam), Anastrozole (AI), Gonadotropin-releasing hormone (GnRH), Letrozole separately, Tam combined with AI, or others regardless of cancer stage (stage 0, 1, 2, 3, 4). At the same time, Traditional Chinese Medicine (TCM) doctors diagnose and treat patients with traditional Chinese medicine (Bian-Zheng-lun-zhi) based on their chief complaiants, such as insomnia, fatigue, nausea, vomiting, and pain to relieve patients' symptoms. Patients will return to clinics as schedule at 1,6, and 12 months and blood tests for female-related hormone which is Estradiol (E2) and Follicle-stimulating hormone (FSH) will be performed. We also apply quality of life questionnaire to evaluate the change of quality of life in these patients. This study will evaluate the clinical efficacy of Chinese-Western medical treatment plans for cancer patients for 1 year.
Intervention code [1] 286445 0
Not applicable
Comparator / control treatment
No intervention control group
Control group
Active

Outcomes
Primary outcome [1] 288777 0
Female-related hormone in serum
Timepoint [1] 288777 0
At baseline and at 1, 6, and 12 months
Secondary outcome [1] 300956 0
Medical outcomes study Short-form-12 health survey(MOS sf-12)
Timepoint [1] 300956 0
At baseline and at 1, 6 and 12 months

Eligibility
Key inclusion criteria
From 2012 in May to 2012 in December, the Taipei Veterans General Hospital in the treatment of cancer patients, regardless of what kind of cancer, regardless of number of installments (stage 0, 1, 2, 3, 4), the age of twenty to eighty years old, take the initiative to the integration of cancer of Chinese and Western medical outpatient or to the TCM special clinic for cancer, requires the use of traditional Chinese medicine in patients.
Minimum age
20 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, chronic liver disease (Bilirubin> 2 mg / dl), chronic kidney disease (Creatinine> 2 mg / dl), acute myocardial infarction patients, patients with the device pacemaker , non-cancer patients, terminal cancer combined heart and lung failure patients, postoperative psychiatric diagnoses were depression patients and cases do not want to sign a consent form.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4838 0
Taiwan, Province Of China
State/province [1] 4838 0

Funding & Sponsors
Funding source category [1] 286679 0
Government body
Name [1] 286679 0
Department of Health, Executive Yuan
Address [1] 286679 0
No.36, Tacheng St., Datong District, Taipei City 10341, Taiwan
Country [1] 286679 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
Committee on Chinese Medicine and Pharmacy
Address
No.6,Shuangcheng St., Jhongshang District, Taipei City, 104 Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285452 0
Hospital
Name [1] 285452 0
Taipei Veterans General Hospital
Address [1] 285452 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country [1] 285452 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To Establish an outpatient platform for the integration of Chinese and Western medicine to treat cancer.Both TCM and modern medicine doctors care a cancer patient , who is based on a common language from patient’s chief complaints and a definite diagnosis provided by an international ICD-9 code, to provide Chinese-Western medical treatment plans. Data were collected from different symptoms of clinical scales with Life Scale efficacy of the enrolled patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37566 0
Prof Fang-Pey Chen
Address 37566 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37566 0
Taiwan, Province Of China
Phone 37566 0
886-2-28757453
Fax 37566 0
Email 37566 0
ctm@vghtpe.gov.tw
Contact person for public queries
Name 37567 0
Prof Jen-Hwey Chiu
Address 37567 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37567 0
Taiwan, Province Of China
Phone 37567 0
886-2-28757453
Fax 37567 0
Email 37567 0
ctm@vghtpe.gov.tw
Contact person for scientific queries
Name 37568 0
Prof Jen-Hwey Chiu
Address 37568 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37568 0
Taiwan, Province Of China
Phone 37568 0
886-2-28757453
Fax 37568 0
Email 37568 0
ctm@vghtpe.gov.tw

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary