Clinical trial NCT01359501: Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
Official title: Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leucopenia
Breast Cancer
Keywords: patients receiving chemotherapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2011-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: WBC Count
timeFrame: 21-31 weeks, which depands on the patients' chemotherapy protocol.
Secondary outcomes:
measure: Score of EORTC QLQ-C30
timeFrame: 21-31 weeks, which depands on the patients' chemotherapy protocol.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Devision of Breast Surgery, China Medical University Hospital
city: Taichung
country: Taiwan
facility: Devision of Breast Surgery, China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Division of General surgery, Tri-Service General Hospital
Study officials:
affiliation: Devision of Breast Surgery, China Medical University Hospital
name: Hwei-Chung Wang, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Chinese Medicine, China Medical University
name: Yi-Chang Su, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: