NCT01142479

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

June 10, 2010

Last Update Submit

May 28, 2014

Conditions

Breast CancerRadiotherapyChinese Herbal Medicine

Keywords

Breast CancerRadiotherapyChinese herbal medicineTPE-1Leukopenia

Outcome Measures

Primary Outcomes (1)

  • the % change of white blood cell(WBC) count

    WBC will be checked before taking TPE ans after taking TPE-1.

    6 weeks

Secondary Outcomes (1)

  • Hemoglobin (Hb)

    6 weeks

Study Arms (2)

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

Chinese herbal medicine decoctionDRUG

100 ml /Qd for 6 weeks(42 days)

Also known as: TPE-1
herbal Aherbal B

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang Ho Hospital

Taipei, Taiwan, 886, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsLeukopenia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice superintendent

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

TW(1)