Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
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ClinicalTrials.gov Identifier: NCT01142479 |
Recruitment Status
:
Completed
First Posted
: June 11, 2010
Last Update Posted
: May 29, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Radiotherapy Chinese Herbal Medicine | Drug: Chinese herbal medicine decoction | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: herbal A
dilute of (TPE-1) decoction.
|
Drug: Chinese herbal medicine decoction
100 ml /Qd for 6 weeks(42 days)
Other Name: TPE-1
|
Experimental: herbal B
TPE-1 decoction (100 ml)
|
Drug: Chinese herbal medicine decoction
100 ml /Qd for 6 weeks(42 days)
Other Name: TPE-1
|
- the % change of white blood cell(WBC) count [ Time Frame: 6 weeks ]WBC will be checked before taking TPE ans after taking TPE-1.
- Hemoglobin (Hb) [ Time Frame: 6 weeks ]The Hb will be checked before and after kaking TPE-1

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142479
Taiwan | |
Shuang Ho Hospital | |
Taipei, Taiwan, 886 |
Responsible Party: | Chung-Hua Hsu, vice superintendent, Taipei City Hospital |
ClinicalTrials.gov Identifier: | NCT01142479 History of Changes |
Other Study ID Numbers: |
TPE-1-breast Ca |
First Posted: | June 11, 2010 Key Record Dates |
Last Update Posted: | May 29, 2014 |
Last Verified: | May 2014 |
Keywords provided by Chung-Hua Hsu, Taipei City Hospital:
Breast Cancer Radiotherapy Chinese herbal medicine TPE-1 Leukopenia |
Additional relevant MeSH terms:
Breast Neoplasms Fatigue Leukopenia Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms Leukocyte Disorders Hematologic Diseases |