UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040584 |
|---|---|
| Receipt number | R000046318 |
| Scientific Title | A Prospective, Multicenter, Observational Study of the Efficacy and Safety of Corticosteroids for Tumor-Induced Central and Peripheral Neuropathic Pain in Cancer Patients. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/29 18:54:08 |
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Basic information
Public title
A Clinical Study of the Efficacy and Safety of Corticosteroids for Cancer-induced Neuropathic Pain.
Acronym
A Clinical Study of the Efficacy and Safety of Corticosteroids for Cancer-induced Neuropathic Pain.
Scientific Title
A Prospective, Multicenter, Observational Study of the Efficacy and Safety of Corticosteroids for Tumor-Induced Central and Peripheral Neuropathic Pain in Cancer Patients.
Scientific Title:Acronym
A Prospective Observational Study of the Efficacy and Safety of Corticosteroids for Tumor-Induced Neuropathic Pain.
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Medicine in general | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of systemic administration of corticosteroids for the treatment of cancer induced central and peripheral neuropathic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the difference of pain intensity (worst pain in 24 hours) between baseline, 72 hours later and 168 hours later.
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
| 999 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old
Patients who have been diagnosed with cancer.
Patients in the hospital
Patients with cancer pain (Brief Pain Inventory short form; worst pain intensity score of 4 or higher in the past 24 hours)
Patients will be scheduled to receive regular corticosteroids for the treatment of cancer-induced neuropathic pain
Key exclusion criteria
Patients whose physicians consider it inappropriate to participate in the research.
Patients who are pregnant, lactating, or may be pregnant.
Patients with diabetes who have poor glycemic control who need additional insulin injections
Patients with an infection-caused fever of 38 degrees or higher
Patients undergoing treatment for an active gastrointestinal ulcer
Patients with diagnoses of hematological malignancy
Serious adverse events due to corticosteroid in the past
Patients who started a new anticancer treatment with a molecularly targeted agency or immune checkpoint inhibitor within 2 weeks, or are scheduled to start the treatment within 1 week
Patients were administrated corticosteroids more than the scheduled dose on the day before the start of treatment
Patients scheduled to administrate corticosteroids more than its regular doses in one week for the treatment of adverse effects by anticancer therapy
Patients who are scheduled to receive surgery for the pain control in a week
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Tagami |
Organization
Tohoku University Graduate School of Medicine
Division name
Palliative Medicine
Zip code
9808575
Address
2-1, Seiryo-machi, Aobaku, Sendai, Miyagi, 9808575, Japan
TEL
0227177366
keita.tagami.d7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Tagami |
Organization
Tohoku University Graduate School of Medicine
Division name
Palliative Medicine
Zip code
9808575
Address
2-1, Seiryo-machi, Aobaku, Sendai, Miyagi, 9808575, Japan
TEL
0227177366
Homepage URL
keita.tagami.d7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics Committee of the Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Japan
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2020 | Year | 06 | Month | 01 | 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
| 2020 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Observational Study
The patients who admit in the hospital from June 6 2020 to December 31 2021 are registered.
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046318
