UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single institution study based on olfaction about an association with various kinds of end-stage symptoms for developing a novel technique of improving quality of life at the end of life
Title of the study (Brief title)	A single institution study about the association with olfaction and various kinds of end-stage symptoms
Region	Japan

Condition
Condition	Dysosmia, Cacogeusia, Depression, Anxiety
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	First, this study aims to determine the association with olfactory and various kinds of symptoms. Second, this study try to identify the offending drug of dysosmia.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Associations with olfactory and end-stage symptoms
Key secondary outcomes	Associations with olfactory and drugs

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	Prevention
Type of intervention	Other
Interventions/Control_1	Test of olfactory, Test of taste, Assessment of depression and anxiety
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hospitalized patients in Ashiya Municipal Hospital who can assess olfactory, taste, depression and anxiety.
Key exclusion criteria	Bedridden or heavily demented patients who can not assess olfactory, taste, depression and anxiety.
Target sample size	50

Research contact person
Name of lead principal investigator	Nakajima Shinichiro, Okamoto Yoshiaki, Niki Kazuyuki
Organization	Ashiya Municipal Hospital, Osaka University
Division name	Department of Palliative Care, Graduate School of Pharmaceutical Sciences, Department of Pharmacy
Address	Hyogo, Ashiya, Asahigaokacho 39-1, Osaka, Suita, Yamadaoka1-6
TEL	06-6879-8250
Email	k-niki@phs.osaka-u.ac.jp

Public contact
Name of contact person	Niki Kazuyuki
Organization	Osaka University, Ashiya Municipal Hospital
Division name	Graduate School of Pharmaceutical Sciences, Department of Pharmacy
Address	Osaka, Suita, Yamadaoka1-6
TEL	06-6879-8250
Homepage URL
Email	k-niki@phs.osaka-u.ac.jp

Sponsor
Institute	Ashiya Municipal Hospital, Osaka University, Graduate School of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Osaka-Yakugyo-Club
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	市立芦屋病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2017 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019333