A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy

NCT00555516 | Unknown Phase 1 DMC

• 1 other identifier: DOH96-TD-I-111-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Chemotherapy; Neutropenia

Keywords

Breast Cancer、 Chemotherapy、 Neutropenia、WBC

Outcome Measures

Primary Outcomes (2)

• % 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 WBC,

• % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in ANC

  % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC

Secondary Outcomes (3)

• QOL analysis using EORTC questionnaires ndex scores

  % 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

  % 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

  % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores

Study Arms (2)

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

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

Interventions

EW02 OTHER

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.

1; 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 20 - 70 years
• Stage T 1-3, N 0-2, M0.
• ECOG performance status of \< 2
• 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:
• 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
• Normal liver function (GOT \< 1.5 x ULN)
• Normal kidney function (Creatinine \< 1.5 x ULN) and no dialysis. 8.Negative of mandatory pregnancy test for women subjects.

You may not qualify if:

• Women under pregnancy or with positive result from mandatory pregnancy test or in lactating; women of child-bearing potential must use adequate contraception
• Prior systemic therapy or radiotherapy for breast cancer
• Known hypersensitivity to bean products
• Serious medical or psychiatric illness that, in the opinion of the principal investigator, would interfere with the ability to adhere to study requirements.
• History of myocardial infraction or angina.
• Uncontrollable acute or chronic diseases, including hypertension or diabetes.
• Second malignancy or cancer metastasis
• HBV or HCV carrier
• WBC below 4000 or ANC below 2000 on D1 of Cycle 1
• Participation in investigational drug study within the past 30 days

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Neihu, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Tsu-Yi Chao, M.D

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsu-Yi Chao, M.D.

CONTACT

+886287927208; tsuyi@ndmctsgh.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: November 1, 2007
• Study Completion: June 1, 2009
• Last Updated: November 8, 2007

Record last verified: 2007-11

Locations

TW (1)