UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058294 |
|---|---|
| Receipt number | R000066644 |
| Scientific Title | Development of a Lifestyle support program for canser patients with persistent Chemotherapy-induced peripheral neuropathy after completion of treatment |
| Date of disclosure of the study information | 2025/06/26 |
| Last modified on | 2026/04/14 16:38:58 |
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Basic information
Public title
Deveoping of Life support program for canser patient suffering chemotherapy induced peripheral neuropathy
Acronym
Development of a Lifestyle support program for canser patients with persistent Chemotherapy-induced peripheral neuropathy after completion of treatment
Scientific Title
Development of a Lifestyle support program for canser patients with persistent Chemotherapy-induced peripheral neuropathy after completion of treatment
Scientific Title:Acronym
Development of a Lifestyle support program for canser patients with persistent Chemotherapy-induced peripheral neuropathy after completion of treatment
Region
| Japan |
Condition
Condition
canser patients chemotherapy induced peripheral neuropathy
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
canser patients chemotherapy induced peripheral neuropathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
FACT-Ntx
Hand Outcomes Questionaire
Pain Catastrophizing Scale
SF-12
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
lifestyle support program
Interventions/Control_2
activity/lifestyle support program
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient persistent Chemotherapy-induced peripheral neuropathy
Key exclusion criteria
dimentia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | AYAKO |
| Middle name | |
| Last name | YOSHIHARA |
Organization
Kobe Womans University
Division name
Nursing
Zip code
650-0046
Address
Kobe city
TEL
08057118951
a-yoshihara@suma.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | AYAKO |
| Middle name | |
| Last name | YOSHIHARA |
Organization
Kobe Womans University
Division name
Nursing
Zip code
657-0046
Address
Kobe city
TEL
08057118951
Homepage URL
a-yoshihara@suma.kobe-wu.ac.jp
Sponsor or person
Institute
Kobe Womans University
Institute
Department
Personal name
Funding Source
Organization
Kobe Womans University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Womans University
Address
Kobe city
Tel
08057118951
a-yoshihara@suma.kobe-wu.ac.jp
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
| 2025 | Year | 06 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066644
