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A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy
This study is currently recruiting participants.
Verified by Tri-Service General Hospital, November 2007
Sponsored by: Tri-Service General Hospital
Information provided by: Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT00555516
  Purpose

Study Hypothesis:

EW02 is a polysaccharide-enriched crude extract from black soybean (BS). BS has been used extensively by the Chinese as food or traditional Chinese medicine for hundreds of years. It has been used as monotherapy to treat Diabetes, menorrhagia and leukorrhea. In combination with others, BS has been used to treat chemotherapy-induced leukopenia on more than 300 pts. The daily doses were 15g bid to 50g tid for 21 days. Side effects were generally mild, including epigastric discomfort, numbness, insomnia, and dry mouth. Recently BS was found to promote myelopoiesis and inhibit tumor growth through immunomodulation. In vitro assays showed BS-PS can stimulate production of cytokines and increase blood progenitors. In vivo studies also demonstrated that BS-PS can reduce neutropenia in mice received 5-FU by stimulating myeloid colony formation. We hypothesize that EW02 can reduce neutropenia in cancer patients who receive chemotherapy without side effects.


Condition Intervention Phase
Breast Cancer
Chemotherapy
Neutropenia
 Other: EW02
 Phase I
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Double-Blind, Randomized, Placebo-Control Pilot Study to Evaluate the Safety and Pharmacodynamic Activities of EW02 in Reducing Neutropenia Caused by Breast Cancer Chemotherapy

Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC, [ Time Frame: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC, ]
  • % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in ANC [ Time Frame: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC ]

Secondary Outcome Measures:
  • QOL analysis using EORTC questionnaires ndex scores [ Time Frame: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores ]
  • Inter-group comparison of Quality of Life survey collected for Cycle 2 [ Time Frame: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores ]
  • Within group analysis (based on "same person comparison"), on the change of WBC/ANC and QOL index scores [ Time Frame: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores ]

Estimated Enrollment: 60
Study Start Date: November 2007
Estimated Study Completion Date: June 2009
Arms Assigned Interventions
1: Active Comparator
  1. The chemotherapy regimen of group 1 is restricted to AC or CAF during the first cycle
  2. Group 1 will receive EW02 for 15 consecutive days during the second cycle
  3. will receive EW02 at 700mg tid/day for 15 consecutive days during the third cycle.
 Other: EW02
  1. Name: EW02
  2. Dosage form: capsule.
  3. Dose(s): 350mg per capsule, 2 capsule tid.
  4. Dosing schedule: 2 capsule tid; 15 days (D3 to D17) of EW02 or placebo in Cycles 2 and 3.
2: Placebo Comparator
  1. The chemotherapy regimen of group 2 is restricted to AC or CAF during the first cycle
  2. Group 2 will receive 15 consecutive days of Placebo
  3. Group 2 will receive EW02 at 700mg tid/day for 15 consecutive days during the third cycle
 Other: EW02
  1. Name: EW02
  2. Dosage form: capsule.
  3. Dose(s): 350mg per capsule, 2 capsule tid.
  4. Dosing schedule: 2 capsule tid; 15 days (D3 to D17) of EW02 or placebo in Cycles 2 and 3.

Detailed Description:

Study procedures:

This is a single-center, double-blind, placebo-controlled parallel, pilot study of oral EW02 in combination with chemotherapy, versus placebo in combination with chemotherapy in breast cancer patients as the primary phase (Cycle 1). The chemotherapy regimen is restricted to one of the following regimens: Doxorubicin + Cyclophosphamide (AC), or Doxorubicin+ Cyclophosphamide+5-FU (CAF) under standardized dosage. The WBC recovery time is similar between these two chemotherapy regimens due to the facts that doxorubicin and cyclophosphamide are overlapped and their dose in CAF is reduced. The principle investigator has clinical experiences that the neutropenia nadir and severity caused by these two regimens are almost the same. Nevertheless, pre-stratification by chemotherapy regimen (stratum AC versus stratum CAF) at randomization will be implemented so that equal sample size of two study products will be allocated under each stratum. It will involve 60 outpatients for breast cancer, who have previously demonstrated a fall unto 1,000 to 3,000/mm3 in WBC count, or unto 500 to 1,500/mm3 in ANC count, on Day 8 or Day 15, whilst on Cycle 1.

The second phase (Cycle 2): EW02 at 700mg tid daily versus placebo group are given at the beginning of Cycle 2 for 15 consecutive days. 60 subjects will be randomized 2:1 to two groups in pre-stratified permuted blocks of six with four subjects assigned to Group 1 (EW02) while two subjects assigned to Group 2 (Placebo). Group 1 will receive EW02 for 15 consecutive days during the second cycle and Group 2 will receive 15 consecutive days of Placebo.

The extension phase (Cycle 3): is designed to collect additional safety data and to ensure all the participants will have the opportunity to receive study drug. Thus, both groups will receive EW02 at 700mg tid/day for 15 consecutive days.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent obtained prior to inclusion in study
  2. Pathologically confirmed breast cancer, whose CBC has shown ever dropped unto 1,000 to 3,000/mm3 in WBC count, or unto 500 to 1,500/mm3 in ANC count, on Day 8 or Day 15, whilst on Cycle 1 of current chemotherapy.
  3. Age 20 - 70 years
  4. Stage T 1-3, N 0-2, M0.
  5. ECOG performance status of < 2
  6. Chemotherapy regimen is restricted to one of the followings:

(1)Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2(AC X 4cycles) or (2)Cyclophosphamide 500 mg/m2 + Doxorubicin 50 mg/m2 + 5-FU 500 mg/m2 (CAF X 6 cycles) 7.Laboratory test results within 30 days prior to study entry:

  1. Hemoglobin 9.0 g/dL for men and 8.7 g/dL for women and platelet> 100,000/mm³ without the need for current, on-going use of erythropoietin or transfusion
  2. Normal liver function (GOT < 1.5 x ULN)
  3. Normal kidney function (Creatinine < 1.5 x ULN) and no dialysis. 8.Negative of mandatory pregnancy test for women subjects.

Exclusion Criteria:

  1. Women under pregnancy or with positive result from mandatory pregnancy test or in lactating; women of child-bearing potential must use adequate contraception
  2. Prior systemic therapy or radiotherapy for breast cancer
  3. Known hypersensitivity to bean products
  4. Serious medical or psychiatric illness that, in the opinion of the principal investigator, would interfere with the ability to adhere to study requirements.
  5. History of myocardial infraction or angina.
  6. Uncontrollable acute or chronic diseases, including hypertension or diabetes.
  7. Second malignancy or cancer metastasis
  8. HBV or HCV carrier
  9. WBC below 4000 or ANC below 2000 on D1 of Cycle 1
  10. Participation in investigational drug study within the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555516

Contacts
Contact: Tsu-Yi Chao, M.D. +886287927208 tsuyi@ndmctsgh.edu.tw

Locations
Taiwan, Neihu
Tri-Service General Hospital Recruiting
Taipei, Neihu, Taiwan, 11490
Contact: Tsu-Yi Chao, M.D.     +886287927208     tsuyi@ndmctsgh.edu.tw    
Principal Investigator: Tsu-Yi Chao, M.D.            
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Tsu-Yi Chao, M.D Tri-Service General Hospital
  More Information

Study ID Numbers: DOH96-TD-I-111-003
Study First Received: November 7, 2007
Last Updated: November 7, 2007
ClinicalTrials.gov Identifier: NCT00555516  
Health Authority: Taiwan: Department of Health

Keywords provided by Tri-Service General Hospital:
Breast Cancer、 Chemotherapy、 Neutropenia、WBC

Study placed in the following topic categories:
Neutropenia
Skin Diseases
Hematologic Diseases
Agranulocytosis
Breast Neoplasms
 Leukocyte Disorders
Leukopenia
Granulocytopenia
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009



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