UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027774
Receipt number R000028425
Scientific Title Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Date of disclosure of the study information 2017/06/16
Last modified on 2020/12/17 14:55:16

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Basic information

Public title

Finding out causes of breakthrough pain focused on circadian rhythm-related factors

Acronym

Finding out causes of breakthrough pain focused on circadian rhythm-related factors

Scientific Title

Finding out causes of breakthrough pain focused on circadian rhythm-related factors

Scientific Title:Acronym

Finding out causes of breakthrough pain focused on circadian rhythm-related factors

Region

Japan


Condition

Condition

Cancer, Sleep disorder, Circadian rhythm disorder

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To reveal the relationship between breakthrough pain and circadian rhythm related factors

Basic objectives2

Others

Basic objectives -Others

The relationship

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between breakthrough pain and circadian rhythm related factors

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Subjects will be received following two interventions for three days.
1.Recording the time of breakthrough pain and the degree of pain (NRS).
2.Measuring circadian rhythm related factors (actigraph, Saint Mary's hospital sleep questionnaire, urine 6-sulfatoxymelatonin and so on).
In addition, assessment anxiety and depression by HAD at getting informed consent.

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

Cancer patients without changing opioid medication for more than three days.

Key exclusion criteria

Cancer patients with heavy dementia, <= PS2, on anticancer drug medicaton.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kazuyuki
Middle name
Last name Niki

Organization

Osaka University/Ashiya Municipal Hospital

Division name

Graduate School of Pharmaceutical Sciences/Department of Pharmacy

Zip code

565-0871

Address

Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1

TEL

06-6879-8250

Email

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


Public contact

Name of contact person

1st name Kazuyuki
Middle name
Last name NIki

Organization

Osaka University/Ashiya Municipal Hospital

Division name

Graduate School of Pharmaceutical Sciences/Department of Pharmacy

Zip code

565-0871

Address

Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1

TEL

06-6879-8250

Homepage URL


Email

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


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ashiya Municipal Hospital Ethical Review Boards

Address

Asahigaokacho 39-1, Ashiya, Hyogo

Tel

0797-31-2156

Email

okamoysh@phs.osaka-u.ac.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

2017 Year 06 Month 16 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

Terminated

Date of protocol fixation

2016 Year 11 Month 30 Day

Date of IRB

2016 Year 06 Month 20 Day

Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date

2021 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

2017 Year 06 Month 15 Day

Last modified on

2020 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name