Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy

Study Overview
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Brief Summary
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Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.

Detailed Description
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TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.

Official Title
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The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy

Conditions
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Breast Cancer, Radiotherapy, Chinese Herbal Medicine

Intervention / Treatment
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* Drug: Chinese herbal medicine decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer age between 18 to 70 yrs finished chemotherapy (adriamycin ), will receiving radiotherapy Chinese population KP$ between 40-100 ECOG < 2 WBC >4X10(9)／L and Hb > 10g/dl Assigned informed concent. Exclusion Criteria: receiving operation during 14 days blood transfusion during one month. ALT >100mg/dL Creatinine >2.0mg/dL Total bilirubin >2.0mg/dL Infection prolation Taking anti-seizure , psychological drugs or any drugs not suitable patients AIDS or any disease diagnosed by physician and not suitable patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: herbal A<br>dilute of (TPE-1) decoction. | Drug: Chinese herbal medicine decoction<br>* 100 ml /Qd for 6 weeks(42 days)<br>* Other names: TPE-1;|
| Experimental: herbal B<br>TPE-1 decoction (100 ml) | Drug: Chinese herbal medicine decoction<br>* 100 ml /Qd for 6 weeks(42 days)<br>* Other names: TPE-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the % change of white blood cell(WBC) count | WBC will be checked before taking TPE ans after taking TPE-1. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) | The Hb will be checked before and after kaking TPE-1 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Radiotherapy, Chinese herbal medicine, TPE-1, Leukopenia