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Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
This study has been completed.
Sponsor:
Taipei City Hospital
Collaborator:
Taipei Medical University Shuang Ho Hospital
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01142479
First received: June 10, 2010
Last updated: May 28, 2014
Last verified: May 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Cancer Radiotherapy Chinese Herbal Medicine | Drug: Chinese herbal medicine decoction | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Chung-Hua Hsu, Taipei City Hospital:
Primary Outcome Measures:
- the % change of white blood cell(WBC) count [ Time Frame: 6 weeks ]WBC will be checked before taking TPE ans after taking TPE-1.
Secondary Outcome Measures:
- Hemoglobin (Hb) [ Time Frame: 6 weeks ]The Hb will be checked before and after kaking TPE-1
| Enrollment: | 60 |
| Study Start Date: | May 2010 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142479
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142479
Locations
| Taiwan | |
| Shuang Ho Hospital | |
| Taipei, Taiwan, 886 | |
Sponsors and Collaborators
Taipei City Hospital
Taipei Medical University Shuang Ho Hospital
More Information
| 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 |
| Study First Received: | June 10, 2010 |
| Last Updated: | May 28, 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 |
ClinicalTrials.gov processed this record on August 22, 2017