UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Acronym	Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Scientific Title	Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Scientific Title:Acronym	Randomized controlled trial of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Region	Japan

Condition
Condition	Malignant glioma
Classification by specialty	Neurosurgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Compariozon of Olanzapine and Rikkunshito for anorexia causing anti malignant brain tumor drug.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL:EORTC QLQ-C308 Anolexia:Numerical Rating Scale Change of body weight, before and after treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Olanzapine
Interventions/Control_2	Rikkunshito
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patient of malignant glioma
Key exclusion criteria	1)Deep coma 2)Uncontrollable Diabetes mellitus 3)Heavy liver dysfunction
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Katayama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of neurosurgery
Zip code	036-8562
Address	Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
TEL	+81-172-39-5115
Email	k.kosuke@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Katayama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of neurosurgery
Zip code	036-8562
Address	Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
TEL	+81-172-39-5115
Homepage URL
Email	k.kosuke@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
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	crb-hirosaki
Address	Zaifu-cho 5, Hirosaki-shi, Aomori, Japan
Tel	+81-172-39-5362
Email	crb-hirosaki@hirosaki-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	17R01001
Org. issuing International ID_1	17R01001
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 26 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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 02 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2020 Year 05 Month 09 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 25 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050628