UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical study on the prevention effect of Docetaxel-induced peripheral neuropathy by compression therapy using surgical gloves and lower limb stockings
Acronym	Glove stocking study for Decetaxel -induced peripheral neuropathy
Scientific Title	Exploratory clinical study on the prevention effect of Docetaxel-induced peripheral neuropathy by compression therapy using surgical gloves and lower limb stockings
Scientific Title:Acronym	Glove stocking study for Decetaxel -induced peripheral neuropathy
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To consider the hypothesis of compression therapy for patients who begin docetaxel therapy for prostate cancer with using surgical gloves and stockings for lower limbs to reduce blood flow in the extremities during administration of anticancer drugs prevent Docetaxel-induced peripheral neuropathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Presence of peripheral neuropathy at the end of 10 courses Grade 1 or higher is judged to be peripheral neuropathy, and Grade 0 or higher is judged to be no peripheral neuropathy based on the CTCAE ver 5.0.
Key secondary outcomes	Changes in the nails at the end of the 10 courses Based on the CTCAE ver 5.0, the "Peripheral Nerve Damage and Nail Questionnaire" is used to evaluate Grade 1 or higher as nail damage and Grade 0 as no nail damage.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	:Double surgical gloves that are one size smaller than the appropriate size, wear them 30 minutes before docetaxel administration, and remove the gloves 30 minutes after docetaxel administration. :Appropriate venous thrombus prevention stockings should be worn 30 minutes before docetaxel administration, and the stockings should be removed 8 hours after docetaxel administration. :Other supportive care is optional. :In principle, administration of prohibited drugs as described below is prohibited.
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
Key inclusion criteria	1) Prostate cancer patients with docetaxel therapy 2) Patients who are over 20 years old and who have obtained informed consent
Key exclusion criteria	1) Patients with peripheral neuropathy at the start of the study 2) Patients who have received medication that may cause peripheral neuropathy in the past. 3) Other patients who are judged inappropriate by the research doctor
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Takuma Middle name Last name Kato
Organization	Kagawa university
Division name	Department of Urology, faculty of medicine
Zip code	761-0793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	087-891-2202
Email	takuma_k@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Kato
Organization	Kagawa university
Division name	Department of Urology, faculty of medicine
Zip code	761-0793
Address	Department of Urology, faculty of medicine
TEL	087-891-2202
Homepage URL
Email	takuma_k@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa university hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kagawa University School of Medicine Ethics Review Committee
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel	087-898-5111
Email	chiken@med.kagawa-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	香川大学医学部付属病院（香川県）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 21 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	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 30 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 05 Month 27 Day
Last follow-up date	2022 Year 07 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 08 Month 21 Day
Last modified on	2020 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043064