UMIN-CTR Clinical Trial

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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