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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01142479

Enrollment

Registered

2010-06-11

Start date

2010-05-31

Completion date

Unknown

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chinese Herbal Medicine, Radiotherapy

Keywords

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

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.

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.

Interventions

DRUGChinese herbal medicine decoction

100 ml /Qd for 6 weeks(42 days)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
the % change of white blood cell(WBC) count	6 weeks	WBC will be checked before taking TPE ans after taking TPE-1.

Secondary

Measure	Time frame	Description
Hemoglobin (Hb)	6 weeks	The Hb will be checked before and after kaking TPE-1

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026