Study of Danggui Buxue Decoction in Preventing Neutropenia (DIPE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Kunwei Shen, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT02005783
First received: December 4, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Grade 3/4 Neutropenia
Febrile Neutropenia
Drug: DBD
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • incidence of grade 3/4 neutropenia [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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:
  • times of grade 3/4 neutropenia per cycle of chemotherapy [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.


Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005783

Contacts
Contact: Xiaosong Chen, Dr 64370045 ext 602205 chenxiaosong0156@hotmail.com

Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Xiaosong Chen, Dr.    0086-64370045 ext 602205    chenxiaosong0156@hotmail.com   
Principal Investigator: Kunwei Shen, Pro.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Kunwei Shen, Dr Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  More Information

No publications provided

Responsible Party: Kunwei Shen, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02005783     History of Changes
Other Study ID Numbers: DIPE
Study First Received: December 4, 2013
Last Updated: July 25, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 19, 2014