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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by China Medical University Hospital
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01359501
First received: May 1, 2011
Last updated: October 21, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Leucopenia
Breast Cancer
Drug: Chinese medical treatment-LCH1
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • WBC Count [ Time Frame: 21-31 weeks, which depands on the patients' chemotherapy protocol. ] [ Designated as safety issue: Yes ]

    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:
  • Score of EORTC QLQ-C30 [ Time Frame: 21-31 weeks, which depands on the patients' chemotherapy protocol. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359501

Contacts
Contact: Lin Jui-Shan, MD., PhD. 886-4-22053366 ext 3105 taco423@ms26.hinet.net

Locations
Taiwan
Devision of Breast Surgery, China Medical University Hospital Enrolling by invitation
Taichung, Taiwan, 40421
Devision of Breast Surgery, China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Jui-shan Lin, MD., PhD.    886-22053366 ext 3105    taco423@ms26.hinet.net   
Division of General surgery, Tri-Service General Hospital Enrolling by invitation
Taipei City, Taiwan, 114
Sponsors and Collaborators
China Medical University Hospital
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
  More Information

No publications provided

Responsible Party: Director of Surgery Department, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01359501     History of Changes
Other Study ID Numbers: DMR99-IRB-259, CCMP99-RD-050
Study First Received: May 1, 2011
Last Updated: October 21, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by China Medical University Hospital:
patients receiving chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Leukopenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014