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

NCT ID: NCT01142479

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Radiotherapy Chinese Herbal Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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herbal A

dilute of (TPE-1) decoction.

Group Type PLACEBO_COMPARATOR

Chinese herbal medicine decoction

Intervention Type DRUG

100 ml /Qd for 6 weeks(42 days)

herbal B

TPE-1 decoction (100 ml)

Group Type EXPERIMENTAL

Chinese herbal medicine decoction

Intervention Type DRUG

100 ml /Qd for 6 weeks(42 days)

Interventions

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Chinese herbal medicine decoction

100 ml /Qd for 6 weeks(42 days)

Intervention Type DRUG

Other Intervention Names

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TPE-1

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chung-Hua Hsu

vice superintendent

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shuang Ho Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TPE-1-breast Ca

Identifier Type: -

Identifier Source: org_study_id

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