Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
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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 |
- 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.
- 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 |
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| Contact: Lin Jui-Shan, MD., PhD. | 886-4-22053366 ext 3105 | taco423@ms26.hinet.net |
| 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 | |
| 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 May 21, 2013