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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024242
Receipt No. R000027915
Scientific Title The effect that helped the nonpharmacologic therapy for peripheral neuropathy with the TC therapy
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/30

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Basic information
Public title The effect that helped the nonpharmacologic therapy for peripheral neuropathy with the TC therapy
Acronym The effect that helped the nonpharmacologic therapy for peripheral neuropathy with the TC therapy
Scientific Title The effect that helped the nonpharmacologic therapy for peripheral neuropathy with the TC therapy
Scientific Title:Acronym The effect that helped the nonpharmacologic therapy for peripheral neuropathy with the TC therapy
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Our ward is the chemotherapy center, and there are many patients receiving TC therapy. One of the side effects of this treatment has peripheral neuropathy, and, as for most of the treated patient, there is much accusing the pain by the trouble to everyday life due to peripheral neuropathy. Peripheral neuropathy with the chemotherapy greatly influences continuation of quality of life and the treatment of the patient who is not a serious side effect. Improvement of peripheral neuropathy is seen by canceling the dosage of the anticancer agent from an early stage, but there is the characteristic to be easy to be prolonged when I appear once and falls down when a symptom turns worse, and it is thought that the influence on everyday life is big. It is important prevention or that I do not let you increase for peripheral neuropathy to continue, and to cure. Therefore I perform the exercise of hands and feet which are one of the means to soften a symptom and I was effective in not letting you prevent peripheral neuropathy by taking good care or reinforce muscular strength maintenance and the blood circulation of hands and feet or study it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of FACT
Change of the grip
Impression of the patient
Key secondary outcomes

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Exercise of hands and feet
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient who can perform a nonpharmacologic therapy (exercise of hands and feet) in the selves who are hospitalized, and perform TC therapy
Key exclusion criteria Unavailable
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Harano
Organization Incorporated administrative agency national hospital mechanism Kyushu medical center
Division name Chemotherapy center
Zip code
Address 1-8-1, Jigyohama, Chuo-ku, Fukuoka-shi, Fukuoka
TEL 092-852-0700
Email 10eb@qmed.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Harano
Organization Incorporated administrative agency national hospital mechanism Kyushu medical center
Division name Chemotherapy center
Zip code
Address 1-8-1, Jigyohama, Chuo-ku, Fukuoka-shi, Fukuoka
TEL 092-852-0700
Homepage URL
Email 10eb@qmed.hosp.go.jp

Sponsor
Institute Incorporated administrative agency national hospital mechanism Kyushu medical center (clinical study center)
Institute
Department

Funding Source
Organization Unavailable
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 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
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 30 Day
Last modified on
2016 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027915

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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