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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Breast Cancer; Radiotherapy; Chinese Herbal Medicine	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

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Study Type :	Interventional (Clinical Trial)
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 2010
Actual Primary Completion Date :	April 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

1. Hemoglobin (Hb) [ Time Frame: 6 weeks ]
   The Hb will be checked before and after kaking TPE-1

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Taiwan
Shuang Ho Hospital
Taipei, Taiwan, 886

Sponsors and Collaborators

Taipei City Hospital

Taipei Medical University Shuang Ho Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	June 11, 2010
Last Update Posted:	May 29, 2014
Last Verified:	May 2014

Keywords provided by Chung-Hua Hsu, Taipei City Hospital:

Breast Cancer; Radiotherapy; Chinese herbal medicine; TPE-1; Leukopenia

Additional relevant MeSH terms:

Breast Neoplasms; Fatigue; Leukopenia; Neoplasms by Site; Neoplasms	Breast Diseases; Skin Diseases; Signs and Symptoms; Leukocyte Disorders; Hematologic Diseases