Compound Herbal Formula (TPE-1) for Leukopenia and Cancer... | NCT01142479

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

NCT01142479

Sponsor

Taipei City Hospital

Status

Completed

Last Update Posted

May 29, 2014Estimated

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Breast Cancer
Radiotherapy
Chinese Herbal Medicine

Interventions

Chinese herbal medicine decoction

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Not provided

First Submitted Date

Jun 10, 2010

First Submission Date that Met QC Criteria

Jun 10, 2010

First Posted Date

Jun 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2014

Last Update Posted Date

May 29, 2014Estimated

Name	Class
Taipei Medical University Shuang Ho Hospital	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
herbal A	Placebo Comparator	dilute of (TPE-1) decoction.	Drug: Chinese herbal medicine decoction
herbal B	Experimental	TPE-1 decoction (100 ml)	Drug: Chinese herbal medicine decoction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chinese herbal medicine decoction	Drug	100 ml /Qd for 6 weeks(42 days)	herbal A herbal B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Shuang Ho Hospital		Taipei	Taiwan	886	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D007970	Leukopenia

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

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