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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038056
Receipt No. R000043351
Scientific Title The effect of compression therapy using surgical gloves on taxane-induced peripheral neuropathy(randomized control trial)
Date of disclosure of the study information 2019/11/01
Last modified on 2019/09/19

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Basic information
Public title The effect of compression therapy using surgical gloves on taxane-induced peripheral neuropathy(randomized control trial)
Acronym compression therapy(taxane)
Scientific Title The effect of compression therapy using surgical gloves on taxane-induced peripheral neuropathy(randomized control trial)
Scientific Title:Acronym compression therapy(taxane)
Region
Japan

Condition
Condition lung cancer, gastric cancer, esophageal cancer, breast cancer, endometrial cancer, cervical cancer, ovarian cancer, pancreatic cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluate the efficacy of compression therapy with Surgical Gloves for prevention of taxane-induced neuropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The incidence of taxane-induced peripheral neuropathy grade 2 or higher using the CTCAE version 5.0.
Key secondary outcomes The incidence of peripheral neuropathy grade B,C,D,E using Patient Neurotoxicity Questionnairethe (PNQ).
The incidence of skin and nail tissue disorders using the CTCAE version 5.0. Time to skin and nail tissue disorders
The incidence of taxane-induced peripheral neuropathy grade 1.3.4 using the CTCAE version 5.0.
Time to peripheral neuropathy
Ratio of cases dropping out

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Compression therapy with surgical Gloves all cycle from 30 minutes before administration of taxane therapy to 30 minutes after administration
Interventions/Control_2 no preventation
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with lung cancer, gastric cancer, esophageal cancer, breast cancer, endometrial cancer, cervical cancer, ovarian cancer, and pancreatic cancer who receive taxane-containing-regimen

porfomance status 0-2
patients who do not have latex allergy
Taxane naive
patients who got written informed consent
Key exclusion criteria patients who have CTCAE more than grade1 neuropathy
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Suyama
Organization Hitachi general Hospital
Division name hematology,oncology
Zip code 317-0077
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Email sutaku2468@yahoo.co.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Suyama
Organization Hitachi general hospital
Division name hematology,oncology
Zip code 317-077
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Homepage URL
Email sutaku2468@yahoo.co.jp

Sponsor
Institute Hitachi general hospital
Institute
Department

Funding Source
Organization Hitachi General 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 Hitachi General Hospital
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
Tel 0294231111
Email sutaku2468@yahoo.co.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
2019 Year 11 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
2019 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2024 Year 10 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
2019 Year 09 Month 19 Day
Last modified on
2019 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043351

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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