UMIN-CTR Clinical Trial

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
Institute	Osaka University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028425