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

Phase 2

• Conditions: Leucopenia; Breast Cancer
• Interventions: Drug: Chinese medical treatment-LCH1; Drug: Placebo

• Registration Number: NCT01359501
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-01
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-21
• Last Update Posted: 2012-10-23
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese medical treatment	Chinese medical treatment-LCH1	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
WBC Count	21-31 weeks, which depands on the patients' chemotherapy protocol.	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.

Secondary Outcome Measures

Name	Time	Method
Score of EORTC QLQ-C30	21-31 weeks, which depands on the patients' chemotherapy protocol.	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.

Trial Locations

Locations (2)

Division of General surgery, Tri-Service General Hospital; 🇨🇳 Taipei City, Taiwan

Devision of Breast Surgery, China Medical University Hospital; 🇨🇳 Taichung, Taiwan