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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.
Sponsor:
Collaborator:
Taipei Medical University Shuang Ho Hospital
Information provided by (Responsible Party):
Chung-Hua Hsu, Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01142479
First received: June 10, 2010
Last updated: May 28, 2014
Last verified: May 2014
History of Changes
  Purpose

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
Radiotherapy
Chinese Herbal Medicine
 Drug: Chinese herbal medicine decoction
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

Further study details as provided by Taipei City Hospital:

Primary Outcome Measures:
  • the % change of white blood cell(WBC) count [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    WBC will be checked before taking TPE ans after taking TPE-1.


Secondary Outcome Measures:
  • Hemoglobin (Hb) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142479

Locations
Taiwan
Shuang Ho Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Taipei City Hospital
Taipei Medical University Shuang Ho Hospital
  More Information

No publications provided

Responsible Party: Chung-Hua Hsu, vice superintendent, Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01142479     History of Changes
Other Study ID Numbers: TPE-1-breast Ca
Study First Received: June 10, 2010
Last Updated: May 28, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei City Hospital:
Breast Cancer
Radiotherapy
Chinese herbal medicine
TPE-1
Leukopenia

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 02, 2015