UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008064 |
|---|---|
| Receipt number | R000009500 |
| Scientific Title | Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer. |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2017/11/30 18:08:54 |
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Basic information
Public title
Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer.
Acronym
Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer.
Scientific Title
Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer.
Scientific Title:Acronym
Study of Palonosetron / Dexamethasone / Olanzapine for nausea and vomiting induced chemotherapy for breast cancer.
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 Palonosetron/Dexamethasone/Olanzapine for nausea and vomiting induced AC/EC/FEC (high emetic risk) 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 (Palonosetron/Dexamethasone/Olanzapine) for this trial.
The treatment schedule of
1) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg before administration of chemotherapy.
2) Dexamethasone is intravenous administrated 13.2mg-16.5mg before administration of chomothetrapy. And oral administrated 4mg at after breakfast and dinner on day 2-5.
3) Olanzapine is oral administrated 5mg before dinner or retiring.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Histological confirmation of breast Cancer.
2) age 20 years or more patients.
3) The following treatment is planned.
A) Cyclophosphamide >= 500mg/m2
B) Doxorubicin >= 50mg/m2
C) Epirubicin >= 60mg/m2
4) adequate organ function, defined as WBC >= 3000/mm3 and/or Neu >= 1500/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)they were Advanced or Recurrent breast Cancer patients.
2) they had 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 diabetes mellitus or past history of diabetes mellitus.
12) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 5 days.
13) they had a brain metastasis or suspected case.
14) they had hypersensitivity for Palonosetron or Dexamethason or Olanzapine.
15) they operated radiation therapy
16) 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
ino@cancer-c.pref.saitama.jp
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 Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
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
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
埼玉県立がんセンター，さいたま赤十字病院，自治医大さいたま医療センター，埼玉社会保険病院，赤心堂病院，三井病院，春日部市立病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 31 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009500
