UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047423 |
|---|---|
| Receipt number | R000054081 |
| Scientific Title | Chemotherapy-induced peripheral neuropathy Compression therapy with nitrile gloves Preventive effect-Study by randomized controlled trial- |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2022/06/24 18:22:46 |
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Basic information
Public title
Chemotherapy-induced peripheral neuropathy
Compression therapy with nitrile gloves
Preventive effect-Study by randomized controlled trial-
Acronym
Chemotherapy-induced peripheral neuropathy
Compression therapy with nitrile gloves
Preventive effect-Study by randomized controlled trial-
Scientific Title
Chemotherapy-induced peripheral neuropathy
Compression therapy with nitrile gloves
Preventive effect-Study by randomized controlled trial-
Scientific Title:Acronym
Chemotherapy-induced peripheral neuropathy
Compression therapy with nitrile gloves
Preventive effect-Study by randomized controlled trial-
Region
| Japan |
Condition
Condition
CANCER
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients diagnosed with cancer and receiving chemotherapy using taxane and platinum preparations, pressure therapy using nitrile gloves should be performed to investigate the development of peripheral neuropathy and examine the preventive effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CTCAE
Key secondary outcomes
FACT-GOG NTX Ver.4
NRS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Start of chemotherapy - every day of chemotherapy
Interventions/Control_2
Wear nitrile gloves for 30 minutes immediately before CIPN-prone drug administration, during administration, and 30 minutes after administration
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
Patients diagnosed with cancer and receiving chemotherapy at Nagasaki University Hospital
Patients undergoing preoperative or postoperative chemotherapy or chemotherapy for recurrence
Patients receiving chemotherapy using taxane and platinum preparations
Patients with consent to wear nitrile gloves
Key exclusion criteria
What researchers, etc. deem inappropriate as a researcher
Requests not to participate in the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | mitsue |
| Middle name | |
| Last name | kawata |
Organization
Nagasaki University Hospital
Division name
Chemotherapy room
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197787
hiranomitsue@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | mitsue |
| Middle name | |
| Last name | kawata |
Organization
Nagasaki University Hospital
Division name
Chemotherapy room
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197787
Homepage URL
hiranomitsue@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
0958197787
hiranomitsue@nagasaki-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
| 2022 | Year | 06 | Month | 20 | 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
| 2022 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054081
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
