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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044105
Receipt No. R000048966
Scientific Title status of usage of olanzapine in patients with malignancies at our hospital
Date of disclosure of the study information 2021/05/05
Last modified on 2021/05/04

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Basic information
Public title status of usage of olanzapine in patients with malignancies at our hospital
Acronym status of usage of olanzapine in patients with malignancies at our hospital
Scientific Title status of usage of olanzapine in patients with malignancies at our hospital
Scientific Title:Acronym status of usage of olanzapine in patients with malignancies at our hospital
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To understand the purpose, effects, and adverse events of olanzapine in patients with malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate of symptom relief with olanzapine for each symptom
Key secondary outcomes Duration of prescription, reason for stopping prescription, number of days alive or days to end of treatment after starting, side effects

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with malignant tumor disease who received a prescription for olanzapine at Kanto Central Hospital of the Public School Mutual Aid Association between 2008, when olanzapine was launched, and May 2020.
Key exclusion criteria Those who were prescribed the drug to treat comorbidities unrelated to malignancy. Those who refused to participate in the study by opting out.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Natsuki
Middle name
Last name Nakagawa
Organization Kanto Central Hospital of the Mutual Aid Association School of Teachers
Division name Respiratory Medicine
Zip code 158-8531
Address 6-25-1 Kamiyoga, Setagaya-ku, Tokyo
TEL 03-3429-1171
Email nnakagawautmedsle@yahoo.co.jp

Public contact
Name of contact person
1st name Natsuki
Middle name
Last name Nakagawa
Organization Kanto Central Hospital of the Mutual Aid Association School of Teachers
Division name Respiratory Medicine
Zip code 158-8531
Address 6-25-1 Kamiyoga, Setagaya-ku, Tokyo
TEL 03-3429-1171
Homepage URL https://www.kanto-ctr-hsp.com
Email nnakagawautmedsle@yahoo.co.jp

Sponsor
Institute Kanto Central Hospital of the Mutual Aid Association School of Teachers (Clinical Research Center)
Institute
Department

Funding Source
Organization Kanto Central Hospital of the Mutual Aid Association School of Teachers (Clinical Research Center)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kanto Central Hospital of the Mutual Aid Association School of Teachers
Address 6-25-1 Kamiyoga, Setagaya-ku, Tokyo
Tel 03-3429-1171
Email nnakagawautmedsle@yahoo.co.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
2021 Year 05 Month 05 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 41
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 No longer recruiting
Date of protocol fixation
2020 Year 09 Month 03 Day
Date of IRB
2020 Year 09 Month 18 Day
Anticipated trial start date
2020 Year 09 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 01 Month 15 Day

Other
Other related information Using the electronic medical record database, patients who met the inclusion criteria were comprehensively searched and those who met the exclusion criteria were excluded, and the following data were extracted.
The following data were extracted.
-age, sex, name of malignant tumor causing symptoms, presence or absence and location of distant metastasis, and presence or absence of surgery, radiation therapy, or drug therapy for malignant tumor.
-The symptoms that led to the prescription of olanzapine or Zyprexa, and changes in these symptoms over time after the prescription.
-The presence or absence of chemotherapy at the time of prescription.
-The duration of prescription, reason for discontinuing prescription, and any possible side effects.
-The duration of the prescription, the reason for stopping the prescription, and the number of days the patient has survived since starting the drug or the number of days until the end of the diagnosis.

Management information
Registered date
2021 Year 05 Month 04 Day
Last modified on
2021 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048966

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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