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

Last updated: May 28, 2014
Sponsor: Taipei City Hospital
Overall Status: Completed

Phase

2/3

Condition

Breast Cancer

White Cell Disorders

Cancer Treatment

Treatment

N/A

Clinical Study ID

NCT01142479
TPE-1-breast Ca
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 60
Study Start date:
May 01, 2010
Estimated Completion Date:

Study 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.

Connect with a study center

  • Shuang Ho Hospital

    Taipei, 886
    Taiwan

    Site Not Available

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