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

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Chemotherapy

Neutropenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:EW02Name: EW02 Dosage form: capsule. Dose(s): 350mg per capsule, 2 capsule tid. Dosing schedule: 2 capsule tid; 15 days (D3 to D17) of EW02 or placebo in Cycles 2 and 3.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1The chemotherapy regimen of group 1 is restricted to AC or CAF during the first cycle Group 1 will receive EW02 for 15 consecutive days during the second cycle will receive EW02 at 700mg tid/day for 15 consecutive days during the third cycle.

2The chemotherapy regimen of group 2 is restricted to AC or CAF during the first cycle Group 2 will receive 15 consecutive days of Placebo Group 2 will receive EW02 at 700mg tid/day for 15 consecutive days during the third cycle

Study Status

Unknown status

Start Date: November 2007

Completed Date: June 2009

Phase: Phase 1/Phase 2

Type: Interventional

Design:

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

Secondary Outcome: QOL analysis using EORTC questionnaires ndex scores

Study sponsors, principal investigator, and references

Principal Investigator: Tsu-Yi Chao, M.D

Lead Sponsor: Tri-Service General Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00555516

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