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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020533
Receipt No. 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

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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
Email 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
Email oku0215@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023699

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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