UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020533 |
|---|---|
| Receipt number | R000023699 |
| Scientific Title | Effectiveness of M-Test for oxaliplatin-induced peripheral neuropathy |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2017/03/07 09:26:49 |
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Basic information
Public title
Effectiveness of M-Test for oxaliplatin-induced peripheral neuropathy
Acronym
The single-group study on the effectiveness of M-Test to peripheral neuropathy caused by oxaliplatin for colorectal cancer patient
Scientific Title
Effectiveness of M-Test for oxaliplatin-induced peripheral neuropathy
Scientific Title:Acronym
The single-group study on the effectiveness of M-Test to peripheral neuropathy caused by oxaliplatin for colorectal cancer patient
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We carry out M-Test for colorectal cancer patients with peripheral neuropathy
due to oxaliplatin and examine the effectiveness of M-Test. FACT-v4.0 and the questionnaire are used for the evaluation of subjective symptoms. Thermography and CTCAE-v4.0 are used for the evaluation of objectives symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Using valid acupuncture point to stimulate the skin's surface with the micro cone, we assess subjective symptoms of peripheral neuropathy before and after.
2 or 3 weeks after intervention
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We intervene from Feb.2015 to Mar. 2017. A micro cone is applied to the outpatient with Grade 1 and over of oxaliplatin-induced CIPN. It is attached on a valid acupuncture point of the surface where pain or tension is induced by 30 body movements for 2 or 3 weeks until next chemotherapy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who gives permission. The person without cognitive problems, without conversation problems and can sit without problems. The person who agreed to this study.
Key exclusion criteria
We exclude the following patients those with metabolic diseases, toxic diseases, hereditary neuropathy and autoimmune diseases.
The person who a lead principal investigator judged to be inappropriate as a subject.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Oku |
Organization
University of Miyazaki
Division name
school of nursing faculty of medicine
Zip code
Address
5200 Kihara Kiyotake-cho Miyazaki-shi
TEL
0985-85-9826
oku0215@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Oku |
Organization
University of Miyazaki
Division name
school of nursing faculty of medicine
Zip code
Address
5200 Kihara Kiyotake-cho Miyazaki-shi
TEL
0985-85-9826
Homepage URL
oku0215@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
宮崎大学医学部附属病院（宮崎県）、藤元総合病院（宮崎県）、三州病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2017 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023699
| 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 |
