Study of Danggui Buxue Decoction in Preventing Neutropenia

NCT02005783 | Completed Phase 2 DMC

• 1 other identifier: RJBC1302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Grade 3/4 Neutropenia; Febrile Neutropenia

Keywords

incidence of grade 3/4 neutropenia; incidence of febrile neutropenia; time to neutropenia recovery; safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• times of grade 3/4 neutropenia per cycle of chemotherapy

  3 weeks

• incidence of febrile neutropenia

  3 weeks

• the time to neutropenia recovery

  2 months

Study Arms (2)

DBD arm

EXPERIMENTAL

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; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

EC/TC

OTHER

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; Drug: Cyclophosphamide; Drug: Docetaxel

Interventions

DBD DRUG

DBD:one dose of medicine twice per day, orally

Also known as: Danggui Buxue Decoction

DBD arm

Epirubicin DRUG

Epirubicin:90mg/m2, d1, q3w\*4

DBD arm; EC/TC

Cyclophosphamide DRUG

Cyclophosphamide:600mg/m2, d1, q3w\*4

DBD arm; EC/TC

Docetaxel DRUG

Docetaxel:75mg/m2, d1, q3w\*4

DBD arm; EC/TC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

danggui buxue decoction; Epirubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Kunwei Shen, Dr

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-05

Locations

CN (1)