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

Primary Purpose

Breast Cancer, Radiotherapy, Chinese Herbal Medicine

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Chinese herbal medicine decoction
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Radiotherapy, Chinese herbal medicine, TPE-1, Leukopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shuang Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

herbal A

herbal B

Arm Description

dilute of (TPE-1) decoction.

TPE-1 decoction (100 ml)

Outcomes

Primary Outcome Measures

the % change of white blood cell(WBC) count
WBC will be checked before taking TPE ans after taking TPE-1.

Secondary Outcome Measures

Hemoglobin (Hb)
The Hb will be checked before and after kaking TPE-1

Full Information

First Posted
June 10, 2010
Last Updated
May 28, 2014
Sponsor
Taipei City Hospital
Collaborators
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01142479
Brief Title
Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Official Title
The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
Collaborators
Taipei Medical University Shuang Ho Hospital

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiotherapy, Chinese Herbal Medicine
Keywords
Breast Cancer, Radiotherapy, Chinese herbal medicine, TPE-1, Leukopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Shuang Ho Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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