UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030716 |
|---|---|
| Receipt number | R000035068 |
| Scientific Title | Examination of the sensory threshold in patients with cancer pain and opioid treatment |
| Date of disclosure of the study information | 2018/01/07 |
| Last modified on | 2022/07/13 20:35:20 |
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Basic information
Public title
Examination of the sensory threshold in patients with cancer pain and opioid treatment
Acronym
Sensory threshold in opioid use
Scientific Title
Examination of the sensory threshold in patients with cancer pain and opioid treatment
Scientific Title:Acronym
Sensory threshold in opioid use
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Hematology and clinical oncology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of opioid use on the sensory function in patines with cancer pain
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensory threthold, pain threshold
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We evaluate sensory threthold using Sensory Nerve Testing Equipment(Neurometer) providing current on patient's skin
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.more or equal 20years, belw 90years
2.more or equal 4 of Numerical Rating Scale
Key exclusion criteria
1.Skin diseases at test skin
2.History of serious allergy
3.Severe noncnacer pain
4.Sensory disturbance
5.Diabetes
6.Serious heart diseases and lung diseases
7.Consciousness disturbance, Dementia, Mental disorder
8.Aphasia, Auditory disturbance, Dysopia
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Kanai |
Organization
Kitasato University Hospital
Division name
Anesthesiology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
kanaiakifumi@aol.com
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Kanai |
Organization
Kitasato University Hospital
Division name
Anesthesiology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
Homepage URL
kanaiakifumi@aol.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kitasato University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
Tel
042-778-8111
kanaiakifumi@aol.com
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
| 2018 | Year | 01 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2018 | Year | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035068
