UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034145 |
|---|---|
| Receipt number | R000038894 |
| Scientific Title | The effect of compression therapy using surgical gloves on (R-)CHOP therapy induced peripheral neuropathy(randomized control trial) |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2024/03/19 14:53:56 |
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Basic information
Public title
The effect of compression therapy using surgical gloves on (R-)CHOP therapy induced peripheral neuropathy(randomized control trial)
Acronym
compression therapy (R-CHOP)
Scientific Title
The effect of compression therapy using surgical gloves on (R-)CHOP therapy induced peripheral neuropathy(randomized control trial)
Scientific Title:Acronym
compression therapy (R-CHOP)
Region
| Japan |
Condition
Condition
non-Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We study whether compression therapy with surgical gloves is effective for reducing (R-)CHOP induced peripheral neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of (R-)CHOP induced peripheral neuropathy grade 2 or higher between the compression hand and control hand using the CTCAE version 4.0 at one month after treatment
Key secondary outcomes
The incidence of (R-)CHOP induced peripheral neuropathy grade 1 or higher between the compression hand and control hand using the CTCAE version 4.0 at following times:before each treatment cycle, and half year after treatment, and one year after treatment
The incidence of (R-)CHOP induced peripheral neuropathy grade B or higher between the compression hand and control hand using the PNQ at following times :before each treatment cycle, and one month after treatment, half year after treatment, and one year after treatment
withdraw from compression therapy
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For every vincristine infusion, each patients wear two Surgical groves of the same size on their dominant hand for only 100 min: during the 30 min before the administration of vincristine, during the 10 min vincrestine infusion itself, and during the 60 min after the end of the infusion.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with untreated malignant lymphoma who receive (R-)CHOP therapy untreated malignant lymphoma
porfomance status 0-2
patients who do not have latex allergy
patients who got written informed consent
Key exclusion criteria
patients who treat stem cell transplantation for hematological malignancy
Target sample size
103
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suyama Takuya |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL
0294231111
sutaku2468@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suyama Takuya |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
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
Kanmon medical center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日立総合病院(茨城県)，関門医療ｾﾝﾀｰ(山口県)
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 30 | Day |
Other
Other related information
Intervention study
Patients who recieve (R-)CHOP therapy from novemver 2018 to october 2023.
Items to be measured:age,sex,diagnosis,PS,stage,NCCN-IPI,charlson comobidity index,past histry,treatment effect, survival date,date of death
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
