Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy in breast cancer patients.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

Conditions
-----------------
Leucopenia, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Chinese medical treatment-LCH1
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese medical treatment<br> | Drug: Chinese medical treatment-LCH1<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Start to take the powder of Placebo 3g*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WBC Count | 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. | 21-31 weeks, which depands on the patients' chemotherapy protocol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of EORTC QLQ-C30 | All the patients will be stratified according to her chemotherapy protocol : FEC*6, FEC*4+Taxotere*4, and FEC*3+Taxotere*3. Score of EORTC QLQ-C30 will be evaluated 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 score will be checked every 3 weeks for 7 times. It will takes 21 weeks to get the score 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. | 21-31 weeks, which depands on the patients' chemotherapy protocol. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients receiving chemotherapy