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

October 21, 2012 updated by: China Medical University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40421
        • Enrolling by invitation
        • Devision of Breast Surgery, China Medical University Hospital
      • Taichung, Taiwan, 404
        • Recruiting
        • Devision of Breast Surgery, China Medical University Hospital
        • Contact:
      • Taipei City, Taiwan, 114
        • Enrolling by invitation
        • Division of General surgery, Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Start to take the powder of Placebo 3g*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.
EXPERIMENTAL: Chinese medical treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of EORTC QLQ-C30
Time Frame: 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.
21-31 weeks, which depands on the patients' chemotherapy protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

Department of Health, Executive Yuan, R.O.C. (Taiwan)

Investigators

  • Principal Investigator: Hwei-Chung Wang, MD., Devision of Breast Surgery, China Medical University Hospital
  • Principal Investigator: Yi-Chang Su, MD., PhD., School of Chinese Medicine, China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

May 1, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (ESTIMATE)

May 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 21, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR99-IRB-259
  • CCMP99-RD-050 (OTHER_GRANT: CCMP99-RD-050)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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