UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029579 |
|---|---|
| Receipt number | R000032537 |
| Scientific Title | A prospective observational study to evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors |
| Date of disclosure of the study information | 2017/10/25 |
| Last modified on | 2019/04/19 13:14:26 |
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Basic information
Public title
A prospective observational study to evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors
Acronym
A prospective observational study to evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors
Scientific Title
A prospective observational study to evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors
Scientific Title:Acronym
A prospective observational study to evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors
Region
| Japan |
Condition
Condition
Painful tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of neuropathic pain components on pain response to radiotherapy for painful tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain response within three months after the start of radiotherapy
Key secondary outcomes
Pain intensity, Analgesic use, Functional interference, Performance status, Adverse events, Other painful lesions
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
1. 20 years old or over
2. Painful tumors planned to receive radiotherapy
3. Signed informed consent
Key exclusion criteria
1. Some other tumor has more severe pain than the tumor planned to receive radiotherapy
2. Painful tumor planned to receive radiotherapy was previously irradiated
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Natsuo |
| Middle name | |
| Last name | Oya |
Organization
Kumamoto University Hospital
Division name
Department of Radiation Oncology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
TEL
096-373-5261
n-oya@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Saito |
Organization
Kumamoto University Hospital
Division name
Department of Radiation Oncology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
TEL
096-373-5261
Homepage URL
tsaito@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional review board (Kumamoto University Hospital)
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
Tel
096-373-5657
ski-shien@jimu.kumamoto-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 | 10 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: a prospective observational study
Methods: At baseline, the treating radiation oncologists will record whether the tumor pain has a neuropathic component, according to (1) the neuropathic pain diagnostic criteria based on diagnostic imaging, (2) the definition of the International Association for the Study of Pain - Neuropathic Pain Special Interest Group, and (3) the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs. Brief Pain Inventory data will be collected at the start of radiotherapy and one, two, and three months later. We will evaluate the impact of neuropathic pain components on pain response within three months after the start of radiotherapy. In our primary analysis, the presence or absence of neuropathic pain components will be judged according to the neuropathic pain diagnostic criteria based on diagnostic imaging.
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032537
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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