UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031823 |
|---|---|
| Receipt number | R000036346 |
| Scientific Title | A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy |
| Date of disclosure of the study information | 2018/03/21 |
| Last modified on | 2019/03/29 23:43:12 |
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Basic information
Public title
A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy
Acronym
The trial of olanzapine 5mg for breakthrough nausea and voimiting
Scientific Title
A phase II trial evaluating the effect of olanzapine 5mg for breakthrough nausea and vomiting in patients receiving carboplatin based chemotherapy
Scientific Title:Acronym
The trial of olanzapine 5mg for breakthrough nausea and voimiting
Region
| Japan |
Condition
Condition
Malignant tumor (lung cancer, gynecological cancer, etc)
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of olanzapine 5mg orally every 24 hour for 72 hours for the breakthrough nausea and vomiting appeared within 120 hours after administration carboplatin-based moderate emetic chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response (no emesis, no rescue medication) rate during 72 hours after administration of olanzapine.
Key secondary outcomes
The change of difference and percentage for nausea intensity (scale, 0-10) at 30, 60, 120 min and 24 hour after administration of olanzapine, and the degree of nausea relief (scale, 1-5) at 24 hour.
Adverse event.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
olanzapine 5mg orally every 24 hour for 72 hours for the treatment of
breakthrough nausea and vomiting induced by chemotherapy.
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
Male and Female
Key inclusion criteria
(1) Malignant tumor patients except for hematopoietic malignancy.
(2) ECOG performance status 0-2.
(3) 20 years-old over at the time of giving informed consent
(4) Patients who have not had medical history of moderately and/or highly emetogenic chemotherapy regimen
(5) CBDCA dose is AUC 5 or more.
(6) Adequate organ function as defined by; AST and ALT < 5 x normal range, T-Bill <= 2.0 mg/dL. (Each of values are examined within 8days before prior to entry)
(7) Oral ingestion is possible
(8) Patient who got written consent from participation before registration
Key exclusion criteria
(1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds.
(2) Patients who do not have enough whole body state to the antineoplastic agents treatment
(3) Patient undergoing diabetes treatment
(4) Patients with symptomatic brain metastasis
(5) Patients who has a convulsive disorders that need anticonvulsants therapy.
(6) Patients with symptomatic ascites that need therapeutic drainage.
(7) Pregnant, breastfeeding or expecting woman, or patients without intention to contraception
(8) Patients enforced radiotherapy on the period between 6 days before and 6 days after of the date of first therapy.
(9) Patients who are using prophylactic antiemetic therapy drugs other than NK1 receptor antagonist, 5HT3 antagonist or dexamethasone.
(10) Patients who take a medicine regularly antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents.
(11) Judged by the investigator to be inappropriate for this study
(12) Patients who has nausea at the start of chemotherapy
(13) Patients who started opioids within 1 week of chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akimitsu |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Cancer Center Hospital
Division name
Department of pharmacy
Zip code
464-8681
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL
052-762-6111
m.akimitsu@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Akimitsu |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Cancer Center Hospital
Division name
Department of pharmacy
Zip code
464-8681
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL
052-762-6111
Homepage URL
m.akimitsu@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, 464-8681, Japan
Tel
052-762-6111
tmushika@aichi-cc.jp
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
| 2018 | Year | 03 | Month | 21 | 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
84
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
| 2018 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036346
