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

Phase 2

Completed

• Conditions: Breast Cancer; Radiotherapy; Chinese Herbal Medicine
• Interventions: Drug: Chinese herbal medicine decoction

• Registration Number: NCT01142479
• Lead Sponsor: Taipei City Hospital

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
herbal A	Chinese herbal medicine decoction	dilute of (TPE-1) decoction.
herbal B	Chinese herbal medicine decoction	TPE-1 decoction (100 ml)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hemoglobin (Hb)	6 weeks	The Hb will be checked before and after kaking TPE-1

Trial Locations

Locations (1)

Shuang Ho Hospital; 🇨🇳 Taipei, Taiwan