UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046363 |
|---|---|
| Receipt number | R000052298 |
| Scientific Title | Respiratory effects of benzodiazepines in advanced cancer patients receiving opioids: prospective observational study. |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/06/23 18:02:59 |
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Basic information
Public title
Respiratory effects of benzodiazepines in advanced cancer patients receiving opioids: prospective observational study.
Acronym
Respiratory effects of benzodiazepines in advanced cancer patients receiving opioids: prospective observational study.
Scientific Title
Respiratory effects of benzodiazepines in advanced cancer patients receiving opioids: prospective observational study.
Scientific Title:Acronym
Respiratory effects of benzodiazepines in advanced cancer patients receiving opioids: prospective observational study.
Region
| Japan |
Condition
Condition
terminal phase of cancer
Classification by specialty
| Hematology and clinical oncology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that respiratory rate significantly decreases after benzodiazepines in advanced cancer patients receiving opioids.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate changes after benzodiazepines in patients with opioid analgesics.
Key secondary outcomes
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
Advanced cancer patients hospitalized in the palliative care unit of Chiba Cancer Center to receive palliative care.
Key exclusion criteria
1.Head and neck cancer patients
2.Patients with tracheostomies
3.Patients with permanent tracheostomies
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Sakashita |
Organization
Chiba Cancer Center
Division name
Palliative Care Unit
Zip code
260-8717
Address
666-2 Nitona Town, Chuo Ward, Chiba City, Chiba Prefecture, Japan
TEL
043-264-5431
ysakashi@chiba-cc.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Yoshimura |
Organization
Chiba Cancer Center
Division name
Palliative Care Unit
Zip code
260-8717
Address
666-2 Nitona Town, Chuo Ward, Chiba City, Chiba Prefecture, Japan
TEL
043-264-5431
Homepage URL
ayoshimura@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Chiba Cancer Center
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
Chiba Cancer Center
Address
666-2 Nitona Town, Chuo Ward, Chiba City, Chiba Prefecture, Japan
Tel
043-264-5431
rinshokenkyu@chiba-cc.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 | 12 | Month | 13 | 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
40
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
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Upon hospitalization to the palliative care unit, informed consent to attend the clinical trial will be obtained from the patients.
Monitoring of respiratory rate and other parameters will be started with the Bed Sensor System, and patients' background will be recorded.
When opioids and benzodiazepines become necessary for patients' treatment, data will be collected for analysis.
We considered respiratory rate decrease of 3/min to have significant clinical impact, and sample size was calculated as 13, however considering our institutional use of opioids and benzodiazepines, sample size of this study was set as 40.
Patients' data not used for this analysis may be used for other exploratory research about other drug impact on respiratory system, for example, major tranquilizers.
Management information
Registered date
| 2021 | Year | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052298
