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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047423
Receipt No. 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

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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
Email 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
Email hiranomitsue@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054081

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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