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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

December 4, 2013
July 25, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02005783 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Grade 3/4 Neutropenia
  • Febrile Neutropenia
  • 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
  • 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
    Interventions:
    • Drug: DBD
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
  • 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
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2017
December 2014   (final data collection date for primary outcome measure)

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

Female
18 Years to 70 Years
No
Contact: Xiaosong Chen, Dr 64370045 ext 602205 chenxiaosong0156@hotmail.com
China
 
NCT02005783
DIPE
Yes
Kunwei Shen, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Kunwei Shen, Dr Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Jiao Tong University School of Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP