Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
18 Years
N/A
Female
Leucopenia, Breast Cancer
Trial Information
Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
The study will be conducted in the Department of Breast Surgery in China Medical University
Hospital, Taichung. One hundred newly diagnosed breast cancer patient (age ≧18, Stage I, II,
IIIa) will be included. After the diagnosis, the patients will undergo operation. Then, each
patient will receive one of the following protocol of chemotherapy according to her
pathology report and overall evaluation: "FEC*6", "FEC*4+Taxotere*4", and
"FEC*3+Taxotere*3".
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.
Inclusion Criteria:
- Newly diagnosed breast cancer patient (age ≧18, Stage I, II, IIIa)
- Receive chemotherapy after operation
Exclusion Criteria:
- Before receiving operation and chemotherapy, the patient already have other chronic
diseases.
- Already have hematological malignancy and other lethal disease.
- Pregnant.
- Have severe psychological diseases.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
WBC Count
Outcome Description:
All the patients will be stratified according to her chemotherapy protocol : "FEC*6", "FEC*4+Taxotere*4", and "FEC*3+Taxotere*3". The WBC will be checked before receiving each cycle of chemotherapy and at the follow up 3 weeks after the completion of chemotherapy. If the participator receives the protocol "FEC*6", her WBC will be checked every 3 weeks for 7 times. It will takes 21 weeks to get the values of WBC at 7 different time point. And it will takes 31 weeks and 24 weeks for participators receive the protocol "FEC*4+Taxotere*4" and "FEC*3+Taxotere*3", respectively.
Outcome Time Frame:
21-31 weeks, which depands on the patients' chemotherapy protocol.
Safety Issue:
Yes
Principal Investigator
Hwei-Chung Wang, MD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Devision of Breast Surgery, China Medical University Hospital
Authority:
Taiwan: Institutional Review Board
Study ID:
DMR99-IRB-259
NCT ID:
NCT01359501
Start Date:
May 2011
Completion Date:
December 2012
Related Keywords:
- Leucopenia
- Breast Cancer
- patients receiving chemotherapy
- Breast Neoplasms
- Leukopenia
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