UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015386 |
|---|---|
| Receipt number | R000017651 |
| Scientific Title | Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens |
| Date of disclosure of the study information | 2014/10/09 |
| Last modified on | 2017/08/27 19:18:44 |
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Basic information
Public title
Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Acronym
Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Scientific Title
Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Scientific Title:Acronym
Feasibility of Olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving 5-day chemotherapy rejimens
Region
| Japan |
Condition
Condition
Patients receiving multiple chemotherapy including highly or moderate emetogenic agents
Classification by specialty
| Medicine in general | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Olanzapine for anti-emetic therapy. To decide recommended dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility
Key secondary outcomes
To decide recommended dose.
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
Olanzapine before the chemotherapy and on day1-5 + granisetron 1 mg i.v. on day1-5 + dexamethasone 19.8mg i.v. on day1-5
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients receiving multiple chemotherapy ( 5days ) including highly or moderate emetogenic agent.
2) patients had never received any chemotherapy.
3) aged 15 years <=, 75>
4) Eeatern clinical oncology group performans status is 0 to 2.
5) fulfil all following conditions
ANA >= 1,500/mm3
Plt >= 100,000/mm3
Hb>=9.0 g/dl
T.Bil < 2.0 g/dl
AST < 100 IU/L
ALT < 100 IU/L
Cre < 1.5
6) written informed consent from the patients
Key exclusion criteria
a)patients who had diabetes mellitus or past history of diabetes mellitus
b)patients who take adrenaline beginning chemotherapy.
c)patients who take barbituric acid beginning chemotherapy.
d)patients who had received any chemotherapy.
e)patients who take opioid.
f)patients who have nausea or vomiting starting study.
g)Active infectious diseases
h)Severe complications
i)history of hypersensitivity or allergy for study drugs or similar compounds.
j)patients with clinically problematic, psycho-neurologic diseases
k)pregnant, breastfeeding or expecting woman.
l) patients with symptomatic brain metastasis
m)patients with obstruction of gastrointestinal tract, for example ileus etc.
n)patients who are disqualified by attending physicians
o)patients with gastrointestinal cancer
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
National cancer center hospital
Division name
Breast and medical oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ketamura@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Bun |
Organization
National cancer center hospital
Division name
Pharmacy
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
sbun@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017651
