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

7 november 2007 bijgewerkt door: Tri-Service General Hospital

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

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

60

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Taiwan
    • Neihu
      • Taipei, Neihu, Taiwan, 11490
        • Werving
        • Tri-Service General Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Tsu-Yi Chao, M.D.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1
  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.
Ander: 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.
Placebo-vergelijker: 2
  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
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
QOL analysis using EORTC questionnaires ndex scores
Tijdsspanne: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index 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
Tijdsspanne: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores
% 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
Tijdsspanne: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores
% change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tri-Service General Hospital

Onderzoekers

  • Hoofdonderzoeker: Tsu-Yi Chao, M.D, Tri-Service General Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2007

Studie voltooiing (Verwacht)

1 juni 2009

Studieregistratiedata

Eerst ingediend

7 november 2007

Eerst ingediend dat voldeed aan de QC-criteria

7 november 2007

Eerst geplaatst (Schatting)

8 november 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

8 november 2007

Laatste update ingediend die voldeed aan QC-criteria

7 november 2007

Laatst geverifieerd

1 november 2007

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DOH96-TD-I-111-003

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