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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.
Taipei Medical University Shuang Ho Hospital
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital Identifier:
First received: June 10, 2010
Last updated: May 28, 2014
Last verified: May 2014
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
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 Blind (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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01142479

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 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
Chinese herbal medicine

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms
Leukocyte Disorders
Hematologic Diseases processed this record on May 25, 2017