UMIN-CTR Clinical Trial

Basic information
Public title	The study of completion rate and safety of wearing surgical gloves for four hours.
Acronym	The study of completion rate and safety of wearing surgical gloves for four hours.
Scientific Title	The study of completion rate and safety of wearing surgical gloves for four hours.
Scientific Title:Acronym	The study of completion rate and safety of wearing surgical gloves for four hours.
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze safety of wearing surgical gloves to avoid chemotherapy induced peripheral neuropathy for four hours.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	completion rate
Key secondary outcomes	adverse events more than grade 2 of CTCAE during or after this intervention

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Wearing two layers of surgical gloves whose size is one size smaller for four hours.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	perfomance status 0 persons with written consent
Key exclusion criteria	any prior chemotherapy peripheral neuropathy active thrombosis person whose right size of surgical gloves is less than 5.5 or more than 8.5 person who is regarded inappropriate for this study by doctors in charge
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Mizuki Middle name Last name Kurihara
Organization	Japanese Red Cross Shizuoka Hospital
Division name	Obstetrics and Gynecology
Zip code	420-0853
Address	8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL	054-254-4311
Email	mizumizuki0130@gmail.com

Public contact
Name of contact person	1st name Mizuki Middle name Last name Kurihara
Organization	Japanese Red Cross Shizuoka Hospital
Division name	Obstetrics and Gynecology
Zip code	420-0853
Address	8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL	054-254-4311
Homepage URL
Email	mizumizuki0130@gmail.com

Sponsor
Institute	Japanese Red Cross Shizuoka Hospital
Institute
Department

Funding Source
Organization	Japanese Red Cross Shizuoka Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Shizuoka Hospital
Address	8-2 Ote-machi, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Tel	054-254-4311
Email	chiken-srhpp@wonder.ocn.ne.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	静岡赤十字病院（静岡県）

Other administrative information
Date of disclosure of the study information	2022 Year 01 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	20
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	No longer recruiting
Date of protocol fixation	2021 Year 12 Month 25 Day
Date of IRB	2022 Year 01 Month 11 Day
Anticipated trial start date	2022 Year 04 Month 27 Day
Last follow-up date	2022 Year 04 Month 27 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 01 Month 19 Day
Last modified on	2022 Year 05 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052864

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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