UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024242 |
|---|---|
| Receipt number | 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 18:13:59 |
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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
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
10eb@qmed.hosp.go.jp
Sponsor or person
Institute
Incorporated administrative agency national hospital mechanism Kyushu medical center (clinical study center)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027915
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
