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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040584 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | Cancer pain | |||
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Tohoku University Graduate School of Medicine |
Institute | |
Department |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046318 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |