UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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