UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044242 |
|---|---|
| Receipt number | 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 | 2025/04/09 18:46:25 |
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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
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
nnoztag@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Terminated
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
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050527
