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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044242
Receipt No. R000050527
Scientific Title Opioid effect on respiration in cancer patients- prospective observational study
Date of disclosure of the study information 2021/05/18
Last modified on 2021/05/18

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Basic information
Public title Opioid effect on respiration in cancer patients- prospective observational study
Acronym Effect of opioid for cancer pain on respiration
Scientific Title Opioid effect on respiration in cancer patients- prospective observational study
Scientific Title:Acronym Opioid effect on respiration
Region
Japan

Condition
Condition cancer pain
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Measurement of breath holding time in opioid prescribed patients with cancer pain may predict abnormal respiration
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Non-respiratory sensation period can predict abnormal breathing patterns at night
Key secondary outcomes ROC analysis of NRSP threshold for abnormal breathing at night

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cancer pain patients
prescribed opioid
symptom assessment scale <5
Key exclusion criteria unconsciousness
delirium
tracheostomy
pressure pain measurement unavailable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Natsuko
Middle name
Last name Nozaki-Taguchi
Organization Chiba University
Division name Graduate School of Medicine
Zip code 260-8677
Address 1-8-1 Inohana Chuo Chiba Japan
TEL 0432227171
Email nnoztag@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Natsuko
Middle name
Last name Nozaki-Taguchi
Organization Chiba University
Division name Graduate School of Medicine
Zip code 260-8677
Address 1-8-1 Inohana Chuo Chiba Japan
TEL 0432227171
Homepage URL
Email nnoztag@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Japan Society for the promotion of science
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 Chiba University Inohana Division
Address 1-8-1 Inohana Chuo Chiba Japan
Tel 0432227171
Email inohana-rinri@chiba-u.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
2021 Year 05 Month 18 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
2021 Year 02 Month 03 Day
Date of IRB
2021 Year 03 Month 22 Day
Anticipated trial start date
2021 Year 05 Month 18 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In opioid prescribed patients,
using bed sensor system allowing non-contact, non-invasive monitoring,
respiratory rate
irregularity of respiration
apnea time
will be monitored.

Management information
Registered date
2021 Year 05 Month 18 Day
Last modified on
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050527

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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