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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Lung cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | |
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IRB Contact (For public release) | |
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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 |
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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 | |
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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 |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |