Study of Danggui Buxue Decoction in Preventing Neutropenia

Febrile Neutropenia Clinical Trial

— DIPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005783
• Other study ID #: RJBC1302
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: December 29, 2015
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Febrile Neutropenia
• Grade 3/4 Neutropenia
• Neutropenia

Intervention

Drug:
• DBD
DBD:one dose of medicine twice per day, orally
• Epirubicin
Epirubicin:90mg/m2, d1, q3w*4
• Cyclophosphamide
Cyclophosphamide:600mg/m2, d1, q3w*4
• Docetaxel
Docetaxel:75mg/m2, d1, q3w*4

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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