Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After

Status Recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01359501
Study type	Interventional
Source	China Medical University Hospital
Contact	Lin Jui-Shan, MD., PhD.
Phone	886-4-22053366
Email	taco423@ms26.hinet.net
Status	Recruiting
Phase	Phase 2
Start date	May 2011
Completion date	December 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms