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NCT Number: NCT01142479

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chinese Herbal Medicine Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Radiotherapy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shuang Ho Hospital

Taipei, Taiwan, 886

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chinese herbal medicine decoction

Drug

100 ml /Qd for 6 weeks(42 days)

Other names: TPE-1

Primary outcomes

  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.

Secondary outcomes

  1. Hemoglobin (Hb)

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Collaborators

  • Taipei Medical University Shuang Ho Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Jun 11, 2010
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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