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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

NCT02005783•Shanghai Jiao Tong University School of Medicine

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

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

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 1, 2013

Primary Completion Date

August 1, 2015

Completion Date

October 1, 2015

Last Updated

December 30, 2015

Enrollment

ESTIMATED participants

Conditions

Grade 3/4 NeutropeniaFebrile Neutropenia

Interventions

DBD

DRUG

Epirubicin

DRUG

Cyclophosphamide

DRUG

Docetaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Danggui Buxue Decoction in Preventing Neutropenia

Inclusion Criteria

Exclusion Criteria

Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance

Effect of the BioFire FilmArray (BCID2) for the Rapid Detection of Bloodstream Infection in Haematologic Patients With Febrile Neutropenia

Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies

Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma

Antimicrobial Revision in Persistent Febrile Neutropenia