Study of Danggui Buxue Decoction in Preventing Neutropenia

Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005783

Acronym

DIPE

Enrollment

Registered

2013-12-09

Start date

2013-10-31

Completion date

2015-10-31

Last updated

2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Neutropenia, Grade 3/4 Neutropenia

Keywords

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

Brief summary

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.

Interventions

DRUGDBD

DBD:one dose of medicine twice per day, orally

DRUGEpirubicin

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

DRUGCyclophosphamide

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

DRUGDocetaxel

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
incidence of grade 3/4 neutropenia	3 weeks	To compare the incidence of grade 3/4 neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

Secondary

Measure	Time frame	Description
times of grade 3/4 neutropenia per cycle of chemotherapy	3 weeks	To compare the times of grade 3/4 neutropenia per cycle of chemotherapy between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
incidence of febrile neutropenia	3 weeks	to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
the time to neutropenia recovery	2 months	to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026