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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142479
• Other study ID #: TPE-1-breast Ca
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 10, 2010
• Last updated: May 28, 2014
• Start date: May 2010

Study information

• Verified date: May 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chinese Herbal Medicine
• Leukopenia
• Radiotherapy

Intervention

Drug:
• Chinese herbal medicine decoction
100 ml /Qd for 6 weeks(42 days)

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the % change of white blood cell(WBC) count	WBC will be checked before taking TPE ans after taking TPE-1.	6 weeks	Yes
Secondary	Hemoglobin (Hb)	The Hb will be checked before and after kaking TPE-1	6 weeks	Yes