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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01359501
• Other study ID #: DMR99-IRB-259
• Secondary ID: CCMP99-RD-050
• Status: Recruiting
• Phase: Phase 2
• First received: May 1, 2011
• Last updated: October 21, 2012
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: China Medical University Hospital
• Contact: Lin Jui-Shan, MD., PhD.
• Phone: 886-4-22053366
• Email: taco423[@]ms26.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Leucopenia
• Leukopenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Taiwan	Devision of Breast Surgery, China Medical University Hospital	Taichung
Taiwan	Devision of Breast Surgery, China Medical University Hospital	Taichung
Taiwan	Division of General surgery, Tri-Service General Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No