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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034145
Receipt No. 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 2019/08/06

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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 2 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 D 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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
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 For every vincristine infusion, each patients wear two Surgical groves of the same size on their non-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_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 38

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
Email 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
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 Kanmon medical center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
2021 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 30 Day

Other
Other related information Intervention study
Patients who recieve (R-)CHOP therapy from novemver 2018 to october 2020.
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
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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