Breast CancerPhase 1/2NCT00555516
A Pilot Study to Evaluate the Safety and Activities of EW02 in Reducing Neutropenia Caused by Chemotherapy
A Phase 1/2 study testing EW02 in people with Breast Cancer and Chemotherapy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer, Chemotherapy, Neutropenia
- What is being tested?
- EW02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained prior to inclusion in study
- 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:
Show all 10Show fewer
- (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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Neihu, 11490
Tsu-Yi Chao, M.D., +886287927208, tsuyi@ndmctsgh.edu.tw
Tsu-Yi Chao, M.D.
About this 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
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.
Read the 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.
- Conditions
- Breast Cancer, Chemotherapy, Neutropenia
- Being tested
- EW02
- Keywords
- Breast Cancer、 Chemotherapy、 Neutropenia、WBC
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EW02Other
- Name: 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: EW02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC,
Measured: % 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
Measured: % 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
Measured: % 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
Measured: % 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
Measured: % change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in QOL index scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startNov 2007
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Investigators
- Tsu-Yi Chao, M.D, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555516
- Sponsor's protocol ID
- DOH96-TD-I-111-003
- Status last verified
- Nov 2007
- First submitted
- 7 Nov 2007
- Last updated
- 8 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00555516
- Acronym / sponsor ID
- DOH96-TD-I-111-003
- Conditions
- Breast Cancer, Chemotherapy, Neutropenia
- Keywords
- Breast Cancer、 Chemotherapy、 Neutropenia、WBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Nov 2007
- Study completion
- Jun 2009 (estimated)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: EW021. 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. |
| 2 | Placebo comparator | Other: EW021. 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent obtained prior to inclusion in study
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EW021. 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. | Other | 1, 2 |
Primary outcome
% 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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2007.
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsu-Yi Chao, M.D principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EW02 in people with Breast Cancer and Chemotherapy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsu-Yi Chao, M.D. (+886287927208, tsuyi@ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% 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,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2007.