Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00555516
Status:
UNKNOWN
Last Update Posted:
2007-11-08
First Post:
2007-11-07
Brief Title:
A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
A Phase III Double-Blind Randomized Placebo-Control Pilot Study to Evaluate the Safety and Pharmacodynamic Activities of EW02 in Reducing Neutropenia Caused by Breast Cancer Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Cyclophosphamide5-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 1000 to 3000mm3 in WBC count or unto 500 to 1500mm3 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 21 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 tidday for 15 consecutive days
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 Cyclophosphamide5-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 1000 to 3000mm3 in WBC count or unto 500 to 1500mm3 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 21 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 tidday for 15 consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None