Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
NCT ID: NCT01359501
Last Updated: 2012-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2011-05-31
2012-12-31
Brief Summary
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Detailed Description
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Every participator will start to take the powder of Chinese herb-LCH1 after her receiving first time of chemotherapy until she receives the next cycle.(While receiving "FEC", it will be 3 weeks. While receiving "Taxotere", it will be 4 weeks).
Just before receiving the next cycle of chemotherapy, the blood of the participator will be sampled to check her CBC, GOT/GPT, BUN/Cr and tumor maker.
The investigators also adopt the body constitution questionnaire (BCQ) to evaluate the Chinese medical constitutional status, the EORTC QLQ-C30, EORTC QLQ-BR23, and Karnofsky score to evaluate the quality of life, and to evaluate the adverse effects of the adjuvant chemotherapy with the NCI-CTCAE Version 3.0.
Each participator will take the powder of Chinese herb-LCH1 from her first chemotherapy till 3 weeks after the last cycle of chemotherapy. Over all, it will take about 18 weeks (FEC\*6) to 28 weeks (FEC\*4+Taxotere\*4) to complete the treatment.
This study will also investigate the influence of the chemotherapy on the Chinese medical constitutional status, and in order to provide the basis for the complementary treatment for the breast cancer by adjusting and balancing the constitutional status of the patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chinese medical treatment
Chinese medical treatment-LCH1
Start to take the powder of Chinese herb-LCH1 3g\*BID just after the 1st chemotherapy, and Stop 2-3 weeks after the final cycle of chemotherapy.
Placebo
Placebo
Start to take the powder of Placebo 3g\*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.
Interventions
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Chinese medical treatment-LCH1
Start to take the powder of Chinese herb-LCH1 3g\*BID just after the 1st chemotherapy, and Stop 2-3 weeks after the final cycle of chemotherapy.
Placebo
Start to take the powder of Placebo 3g\*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Receive chemotherapy after operation
Exclusion Criteria
* Already have hematological malignancy and other lethal disease.
* Pregnant.
* Have severe psychological diseases.
18 Years
FEMALE
No
Sponsors
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Department of Health, Executive Yuan, R.O.C. (Taiwan)
OTHER_GOV
China Medical University Hospital
OTHER
Responsible Party
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China Medical University Hospital
Principal Investigators
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Hwei-Chung Wang, MD.
Role: PRINCIPAL_INVESTIGATOR
Devision of Breast Surgery, China Medical University Hospital
Yi-Chang Su, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
School of Chinese Medicine, China Medical University
Locations
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Devision of Breast Surgery, China Medical University Hospital
Taichung, Taiwan, Taiwan
Devision of Breast Surgery, China Medical University Hospital
Taichung, Taiwan, Taiwan
Division of General surgery, Tri-Service General Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Jui-shan Lin, MD., PhD.
Role: primary
Other Identifiers
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CCMP99-RD-050
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DMR99-IRB-259
Identifier Type: -
Identifier Source: org_study_id