UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058134 |
|---|---|
| Receipt number | R000066360 |
| Scientific Title | Evaluation of the effectiveness of alternating magnetic field therapy device (AT-04) for chemotherapy-induced peripheral neuropathy |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/08 13:32:12 |
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Basic information
Public title
Examination of the effectiveness of the medical device AT-04 for peripheral neuropathy caused by anti-cancer drugs
Acronym
Examination of the effectiveness of the medical device AT-04 for peripheral neuropathy caused by anti-cancer drugs
Scientific Title
Evaluation of the effectiveness of alternating magnetic field therapy device (AT-04) for chemotherapy-induced peripheral neuropathy
Scientific Title:Acronym
Evaluation of the effectiveness of alternating magnetic field therapy device (AT-04) for chemotherapy-induced peripheral neuropathy
Region
| Japan |
Condition
Condition
Chemotherapy-Induced Peripheral Neuropathy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the efficacy and safety of alternating magnetic field therapy device AT-04 for the treatment of chemotherapy-induced peripheral neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Pain and Numbness Numeric Rating Scale (NRS) at the Final Measurement
Key secondary outcomes
Change in Pain Numeric Rating Scale (NRS) at Each Observation Time Point
Change in EORTC QLQ-C30 and QLQ-CIPN20 Scores and Subscores at Each Observation Time Point
Patient Global Impression of Change (PGI-C) at Each Observation Time Point
Incidence of Adverse Events (CTCAE v.5.0)
Incidence of Device Malfunctions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
AT-04 group: Treatment with the AT-04 alternating magnetic field therapy device. The device's leads were placed on four locations: both armpits and both groins, or the palms of both hands and the soles of both feet. The device was used for 30 minutes each time, at least twice a day (maximum of two hours), for 84 days.
Interventions/Control_2
Sham machine group: Treatment with the Sham machine.The device's leads were placed on four locations: both armpits and both groins, or the palms of both hands and the soles of both feet. The device was used for 30 minutes each time, at least twice a day (maximum of two hours), for 84 days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a 24-hour average pain NRS of 4/10 or more due to CIPN
Patients with peripheral sensory neuropathy of grade 1 or more in any limb based on CTCAE v5.0
Patients with an ECOG performance status of 0 to 2
Patients with a predicted prognosis of 12 weeks or more
Patients who have provided written informed consent
Key exclusion criteria
Patients who disagreed with the informed consent
Patients who are deemed inappropriate by the principal investigator or subinvestigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SUNAO |
| Middle name | |
| Last name | SHOJI |
Organization
Tokai University
Division name
Department of Urology
Zip code
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
sunashoj@tokai.ac.jp
Public contact
Name of contact person
| 1st name | SOICHIRO |
| Middle name | |
| Last name | YUZURIHA |
Organization
Tokai University
Division name
Department of Urology
Zip code
259-1193
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
ys6683@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai 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
Institutional Review Board for Clinical Research, Tokai University
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
Tel
0463-93-1121
ys6683@tokai.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 | 07 | Month | 01 | 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
| 2024 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066360
