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Study of Danggui Buxue Decoction in Preventing Neutropenia (DIPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005783
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Grade 3/4 Neutropenia Febrile Neutropenia Drug: DBD Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer:A Prospective, Randomized Trial
Study Start Date : October 2013
Primary Completion Date : August 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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
Drug: DBD
DBD:one dose of medicine twice per day, orally
Other Name: Danggui Buxue Decoction
Drug: Epirubicin
Epirubicin:90mg/m2, d1, q3w*4
Drug: Cyclophosphamide
Cyclophosphamide:600mg/m2, d1, q3w*4
Drug: Docetaxel
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
Drug: Epirubicin
Epirubicin:90mg/m2, d1, q3w*4
Drug: Cyclophosphamide
Cyclophosphamide:600mg/m2, d1, q3w*4
Drug: Docetaxel
Docetaxel:75mg/m2, d1, q3w*4


Outcome Measures

Primary Outcome Measures :
  1. incidence of grade 3/4 neutropenia [ Time Frame: 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 Outcome Measures :
  1. times of grade 3/4 neutropenia per cycle of chemotherapy [ Time Frame: 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.

  2. incidence of febrile neutropenia [ Time Frame: 3 weeks ]
    to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.

  3. the time to neutropenia recovery [ Time Frame: 2 months ]
    to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005783


Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Kunwei Shen, Dr Ruijin Hospital
More Information

Responsible Party: Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02005783     History of Changes
Other Study ID Numbers: RJBC1302
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: May 2015

Keywords provided by Kunwei Shen, Shanghai Jiao Tong University School of Medicine:
incidence of grade 3/4 neutropenia
incidence of febrile neutropenia
time to neutropenia recovery
safety

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Cyclophosphamide
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors