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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029389
Receipt No. R000029891
Scientific Title Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Date of disclosure of the study information 2017/10/02
Last modified on 2019/05/20

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Basic information
Public title Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Acronym Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Scientific Title Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Scientific Title:Acronym Verification of the effect of hand exercise program on upper extremity function of chemotherapy-induced peripheral neuropathy(CIPN) patients
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify whether improvement of upper extremity / finger function, ADL and QOL is allowed by performing hand exercise program on CIPN patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Michigan Hand Outcome Questionnaire
Key secondary outcomes grip strength, pinch strength, dexterity, tactile threshold, VAS, FACT-Ntx, PCS, nerve conduction velocity study

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 hand exercise program
Interventions/Control_2 not treatment
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 and Female
Key inclusion criteria Cases of cancer chemotherapy being underway and exhibiting symptoms of hands after chemotherapy began.
Cases receiving a disease name notification.
Cases of CIPN diagnosed.
Key exclusion criteria Cases with severe organ damage (liver failure, renal failure, acute heart failure etc).
Cases whose age at registration is under 20 years.
Cases in which clean room treatment is done.
Case which cognitive function is declining(Mini-Mental State Examination: MMSE with 23 or less cases).
Cases of a mental disorder such as depression or schizophrenia disease and a disorder exhibiting symptoms in upper limbs and fingers in the past.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Ikio
Organization Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Rehabilitation
Zip code 852-8511
Address 3-15 mori-mati, nagasaki-si, nagasaki-ken
TEL 095-847-1511
Email y.ikoiko@gmail.com

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Ikio
Organization Japanese Red Cross Society Nagasaki Genbaku Hospital
Division name Department of Rehabilitation
Zip code 852-8511
Address 3-15 mori-mati, nagasaki-si, nagasaki-ken
TEL 095-847-1511
Homepage URL
Email y.ikoiko@gmail.com

Sponsor
Institute Japanese Red Cross Society Nagasaki Genbaku Hospital
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization no
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 Nagasaki University Graduate School of Biomedical Sciences
Address 1-12-4 sakamoto-mati, nagasaki-si, nagasaki-ken
Tel 095-819-7195
Email gakujutu_kikaku@ml.nagasaki-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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 02 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
2016 Year 12 Month 01 Day
Date of IRB
2016 Year 10 Month 13 Day
Anticipated trial start date
2016 Year 12 Month 15 Day
Last follow-up date
2020 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029891

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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