UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016996
Receipt number R000019333
Scientific Title 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
Date of disclosure of the study information 2015/04/01
Last modified on 2017/10/01 13:15:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

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

Acronym

A single institution study about the association with olfaction and various kinds of end-stage symptoms

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name 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

Zip code


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

1st name
Middle name
Last name Niki Kazuyuki

Organization

Osaka University, Ashiya Municipal Hospital

Division name

Graduate School of Pharmaceutical Sciences, Department of Pharmacy

Zip code


Address

Osaka, Suita, Yamadaoka1-6

TEL

06-6879-8250

Homepage URL


Email

k-niki@phs.osaka-u.ac.jp


Sponsor or person

Institute

Ashiya Municipal Hospital, Osaka University, Graduate School of Pharmaceutical Sciences

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2015 Year 03 Month 31 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name