Grade 3/4 NeutropeniaPhase 2DIPENCT02005783
Study of Danggui Buxue Decoction in Preventing Neutropenia
A Phase 2 study testing DBD, Epirubicin and Cyclophosphamide in people with Grade 3/4 Neutropenia and Febrile Neutropenia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Grade 3/4 Neutropenia, Febrile Neutropenia
- What is being tested?
- DBD, Epirubicin and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years and < 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3109/L; Neutrophil ≥ 1.5109/L; PLT ≥ 100109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;
Who cannot join
- Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial
To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.
- Conditions
- Grade 3/4 Neutropenia, Febrile Neutropenia
- Being tested
- DBD, Epirubicin, Cyclophosphamide, Docetaxel
- Keywords
- incidence of grade 3/4 neutropenia, incidence of febrile neutropenia, time to neutropenia recovery, safety
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBDDrug
Also called Danggui Buxue Decoction
DBD:one dose of medicine twice per day, orally
EpirubicinDrug
Epirubicin:90mg/m2, d1, q3w*4
CyclophosphamideDrug
Cyclophosphamide:600mg/m2, d1, q3w*4
DocetaxelDrug
Docetaxel:75mg/m2, d1, q3w*4
| Study group | Role | What they receive |
|---|---|---|
| DBD arm | Experimental | Epirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally Receives: Drug: DBD; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
| EC/TC | Other | Epirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade 3/4 neutropenia
To compare the incidence of grade 3/4 neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
Measured: 3 weeks
Secondary outcomes (3)
times of grade 3/4 neutropenia per cycle of chemotherapy
To compare the times of grade 3/4 neutropenia per cycle of chemotherapy between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
Measured: 3 weeks
incidence of febrile neutropenia
to compare incidence of febrile neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
Measured: 3 weeks
the time to neutropenia recovery
to compare the time to neutropenia recovery between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 3/4 NeutropeniaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, Dr, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005783
- Sponsor's protocol ID
- RJBC1302
- Acronym
- DIPE
- Status last verified
- May 2015
- First submitted
- 4 Dec 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02005783
- Acronym / sponsor ID
- DIPE / RJBC1302
- Conditions
- Grade 3/4 Neutropenia, Febrile Neutropenia
- Keywords
- incidence of grade 3/4 neutropenia, incidence of febrile neutropenia, time to neutropenia recovery, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2013 (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.
To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBD arm | Experimental | Drug: DBD, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DocetaxelEpirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 DBD: one dose of medicine twice per day, orally |
| EC/TC | Other | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DocetaxelEpirubicin: 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 OR; Docetaxel: 75mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged ≥18 years and < 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3109/L; Neutrophil ≥ 1.5109/L; PLT ≥ 100109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;
Key exclusion criteria (1 listed)
- Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia
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 |
|---|---|---|
| DBDAlso: Danggui Buxue DecoctionDBD:one dose of medicine twice per day, orally | Drug | DBD arm |
| EpirubicinEpirubicin:90mg/m2, d1, q3w*4 | Drug | DBD arm, EC/TC |
| CyclophosphamideCyclophosphamide:600mg/m2, d1, q3w*4 | Drug | DBD arm, EC/TC |
| DocetaxelDocetaxel:75mg/m2, d1, q3w*4 | Drug | DBD arm, EC/TC |
Primary outcome
incidence of grade 3/4 neutropenia
Time frame: 3 weeks
To compare the incidence of grade 3/4 neutropenia between EC/TC arm and EC/TC plus DBD arm in breast cancer adjuvant chemotherapy.
3 secondary outcomes
times of grade 3/4 neutropenia per cycle of chemotherapy
Time frame: 3 weeks
incidence of febrile neutropenia
Time frame: 3 weeks
the time to neutropenia recovery
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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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.
Kunwei Shen, Dr principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DBD, Epirubicin and Cyclophosphamide in people with Grade 3/4 Neutropenia and Febrile Neutropenia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Dec 2015. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of grade 3/4 neutropenia (time frame: 3 weeks). 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 30 Dec 2015.