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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004025
Receipt No. R000004841
Scientific Title Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Date of disclosure of the study information 2010/08/10
Last modified on 2017/11/30

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Basic information
Public title Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Acronym Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting
Scientific Title Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Scientific Title:Acronym Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigation the efficacy of Aprepitant/Palonosetron/Dexamethasone for nausea and vomiting induced AC/EC/FEC for adjuvant or neoadjuvant chemotherapy breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients with no emetic episodes and no rescue medication (Complete Response (CR)) for 5 days
Key secondary outcomes Complete Control (CC) rate: defined as no emetic episodes, no rescue medication use, and no more than mild nausea for 5 days.
Time to Treatment Failure: time to first emetic episode or time to administration of rescue therapy, whichever occurred first

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We use three anti emesis drugs (Aprepitant/Palonosetron/Dexamethasone) for this trial.
The treatment schedule of
1) Aprepitant is oral administrated 125mg before administration of 1 hour~1 hour 30min for chemotherapy. And oral administrated 80mg at after breakfast on day 2, 3.
2) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg before administration of chemotherapy.
3) Dexamethasone is intravenous administrated 9.9mg before administration of chemotherapy. And oral administrated 4mg at after breakfast and dinner on day 2-4.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria 1) Histological confirmation of breast Cancer.
2) aged 20 years or more.
3) The following treatment is planned.
Cyclophosphamide >= 500mg/m2
Doxorubicin >= 50mg/m2
Epirubicin >= 60mg/m2
4) adequate oran function, defined as WBC >= 3000/mm3 and/or Neu >=1,500/mm3 ,AST < 5.0xULN IU/L , ALT < 5.0xULN IU/L
5) performance status (PS) 0-2
6) written informed consent from the patients.
Key exclusion criteria The exclusion criteria were as follows; patients were not eligible for this study if
1) Advanced or Recurrent breast Cancer.
2) child-pugh score > 9
3) they had undergone treatment with high emetic risk and moderate emetic risk chemotherapy by Japan society of clinical oncology prior to this study
4) they had undergone treatment with clarithromycin, ketoconazole, itraconazole within 7 days
5) they had undergone treatment with barbiturate, rifampicin, phenytoin, carbamazepine within 4 weeks.
6) they took warfarin.
7) they took oral contraceptive.
8) they had deep venous thrombosis
9) they had ascites or pleural effusion needs paracentesis treatment.
10) they had serious complication.
(intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer.
11) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 4 days.
12) they had a brain metastasis or suspected case.
13) they were operated within 28 day before entry
14) they operated radiation therapy
15) they except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Breast Medical Oncology
Zip code
Address 818 Ina-machi oaza komuro, kita-adachi-gun, Saitama, 362-0806, Japan
TEL 048-722-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name Secretariat Division (Shintoshin Ladies' MammoClinic)
Zip code
Address 3F Captal building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL 048-600-1722
Homepage URL http://www.sbccsg.org/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 10 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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