UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061494 |
|---|---|
| Receipt number | R000070365 |
| Scientific Title | Investigation of rehabilitation for the dysesthesias by chemotherapy induced peripheral neuropathy |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 16:05:49 |
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Basic information
Public title
Investigation of rehabilitation for the dysesthesias by chemotherapy induced peripheral neuropathy
Acronym
CIPN-DM-TENS study
Scientific Title
Investigation of rehabilitation for the dysesthesias by chemotherapy induced peripheral neuropathy
Scientific Title:Acronym
CIPN rehabilitation study
Region
| Japan |
Condition
Condition
Chemotherapy-induced peripheral neuropathy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this exploratory study is to examine the short- and long-term effects of dysesthesia-matched transcutaneous electrical nerve stimulation combined with standard physical therapy in patients with chemotherapy-induced peripheral neuropathy, and to clarify its effects on numbness, pain, sensory disturbance, motor impairment, and interference with daily activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the subjective intensity of numbness assessed using the Numerical Rating Scale. Specifically, changes in NRS before and after each dysesthesia-matched TENS session during the intervention phase and daily changes in NRS across the baseline, intervention, and follow-up phases will be evaluated.
Key secondary outcomes
Secondary outcomes include pain intensity assessed using the Brief Pain Inventory intensity scale, pain interference assessed using the Brief Pain Inventory interference scale, pain distribution assessed using pain drawings, severity of chemotherapy-induced peripheral neuropathy assessed using the Patient Neurotoxicity Questionnaire, neuropathic pain symptoms assessed using the Neuropathic Pain Symptom Inventory, quantitative assessment of the fineness and intensity of dysesthesia using electrical stimulation, vibration sense and superficial sensation as quantitative sensory testing, central sensitization-related symptoms assessed using the CSI-9, pain catastrophizing assessed using the PCS-6, anxiety assessed using the GAD-2, depression assessed using the PHQ-2, balance function assessed using the Berg Balance Scale, physical activity assessed using the Global Physical Activity Questionnaire, and adverse events.
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
The study consists of a 1-week baseline phase with standard physical therapy alone, a 1-month intervention phase with dysesthesia-matched TENS combined with standard physical therapy, and a 1-month follow-up phase without TENS. During the intervention phase, dysesthesia-matched TENS will be delivered for 60 minutes per session, once weekly, for a total of four sessions.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with chemotherapy-induced peripheral neuropathy in the hands and/or feet; 2) age under 80 years; 3) at least 3 months after completion of chemotherapy; 4) diagnosis of chemotherapy-induced peripheral neuropathy by a physician; 5) numbness or pain intensity of 3/10 or higher on the Numerical Rating Scale; 6) ability to provide written informed consent; and 7) permission for electrical stimulation therapy from the attending physician.
Key exclusion criteria
1) Cognitive impairment defined as a Mini-Mental State Examination score of 24 or lower; 2) peripheral neuropathy before chemotherapy, such as neuropathy due to diabetes or central nervous system disease; 3) implanted electrical devices such as a pacemaker; 4) refusal by the participant or family to continue participation during the study; and 5) worsening physical condition or other conditions judged to make continuation of assessment or intervention inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki University
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
0958197967
ynishi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki university
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
095-819-7967
Homepage URL
ynishi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.
Address
1-7-1,sakamoto,nagasaki
Tel
095-819-7900
ynishi@nagasaki-u.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
| 2026 | Year | 05 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070365
