UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037761 |
|---|---|
| Receipt number | R000043064 |
| Scientific Title | Exploratory clinical study on the prevention effect of Docetaxel-induced peripheral neuropathy by compression therapy using surgical gloves and lower limb stockings |
| Date of disclosure of the study information | 2019/08/21 |
| Last modified on | 2020/08/23 21:47:11 |
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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
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
takuma_k@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043064
