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

Sponsor
Taipei City Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01142479
Collaborator
Taipei Medical University Shuang Ho Hospital (Other)
60
Enrollment
1
Location
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chinese herbal medicine decoction
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: herbal A

dilute of (TPE-1) decoction.

Drug: Chinese herbal medicine decoction
100 ml /Qd for 6 weeks(42 days)
Other Names:
  • TPE-1

    		•
    Experimental: herbal B

    TPE-1 decoction (100 ml)

    Drug: Chinese herbal medicine decoction
    100 ml /Qd for 6 weeks(42 days)
    Other Names:
  • TPE-1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the % change of white blood cell(WBC) count [6 weeks]

      WBC will be checked before taking TPE ans after taking TPE-1.

    Secondary Outcome Measures

    1. Hemoglobin (Hb) [6 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Locations

    Site City State Country Postal Code
    1 Shuang Ho Hospital Taipei Taiwan 886

    Sponsors and Collaborators

    • Taipei City Hospital
    • Taipei Medical University Shuang Ho Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chung-Hua Hsu, vice superintendent, Taipei City Hospital
    ClinicalTrials.gov Identifier:
    NCT01142479
    Other Study ID Numbers:
    • TPE-1-breast Ca
    First Posted:
    Jun 11, 2010
    Last Update Posted:
    May 29, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Chung-Hua Hsu, vice superintendent, Taipei City Hospital
    Breast Cancer
    Radiotherapy
    Chinese herbal medicine
    TPE-1
    Leukopenia
    Additional relevant MeSH terms:
    Breast Neoplasms
    Leukopenia

    Study Results

    No Results Posted as of May 29, 2014