Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
May 28, 2014 updated by: Chung-Hua Hsu, Taipei City Hospital
The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 886
- Shuang Ho Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: herbal A
dilute of (TPE-1) decoction.
|
100 ml /Qd for 6 weeks(42 days)
Other Names:
|
|
Experimental: herbal B
TPE-1 decoction (100 ml)
|
100 ml /Qd for 6 weeks(42 days)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the % change of white blood cell(WBC) count
Time Frame: 6 weeks
|
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)
Time Frame: 6 weeks
|
The Hb will be checked before and after kaking TPE-1
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
June 10, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPE-1-breast Ca
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.