UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038056 |
|---|---|
| Receipt number | 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 15:24:14 |
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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
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
sutaku2468@yahoo.co.jp
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043351
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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