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Study of Danggui Buxue Decoction in Preventing Neutropenia

NCT ID: NCT02005783

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.

Detailed Description

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Conditions

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Grade 3/4 Neutropenia Febrile Neutropenia

Keywords

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incidence of grade 3/4 neutropenia incidence of febrile neutropenia time to neutropenia recovery safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DBD arm

Epirubicin: 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4 DBD: one dose of medicine twice per day, orally OR; Docetaxel: 75mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4 DBD: one dose of medicine twice per day, orally

Group Type EXPERIMENTAL

DBD

Intervention Type DRUG

DBD:one dose of medicine twice per day, orally

Epirubicin

Intervention Type DRUG

Epirubicin:90mg/m2, d1, q3w\*4

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide:600mg/m2, d1, q3w\*4

Docetaxel

Intervention Type DRUG

Docetaxel:75mg/m2, d1, q3w\*4

EC/TC

Epirubicin: 90mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4 OR; Docetaxel: 75mg/m2, d1, q3w\*4 Cyclophosphamide: 600mg/m2, d1, q3w\*4

Group Type OTHER

Epirubicin

Intervention Type DRUG

Epirubicin:90mg/m2, d1, q3w\*4

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide:600mg/m2, d1, q3w\*4

Docetaxel

Intervention Type DRUG

Docetaxel:75mg/m2, d1, q3w\*4

Interventions

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DBD

DBD:one dose of medicine twice per day, orally

Intervention Type DRUG

Epirubicin

Epirubicin:90mg/m2, d1, q3w\*4

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide:600mg/m2, d1, q3w\*4

Intervention Type DRUG

Docetaxel

Docetaxel:75mg/m2, d1, q3w\*4

Intervention Type DRUG

Other Intervention Names

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Danggui Buxue Decoction

Eligibility Criteria

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Inclusion Criteria

Women aged ≥18 years and \< 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3\*109/L; Neutrophil ≥ 1.5\*109/L; PLT ≥ 100\*109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;

Exclusion Criteria

Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kunwei Shen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kunwei Shen, Dr

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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RJBC1302

Identifier Type: -

Identifier Source: org_study_id