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Examination of the effectiveness of the medical device AT-04 for peripheral neuropathy caused by anti-cancer drugs

Evaluation of the effectiveness of alternating magnetic field therapy device (AT-04) for chemotherapy-induced peripheral neuropathy - Evaluation of the effectiveness of alternating magnetic field therapy device (AT-04) for chemotherapy-induced peripheral neuropathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058134
Enrollment
30
Registered
2025-07-01
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Interventions

AT-04 group: Treatment with the AT-04 alternating magnetic field therapy device. The device&#39
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

Sponsors

Tokai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients who disagreed with the informed consent Patients who are deemed inappropriate by the principal investigator or subinvestigator.

Design outcomes

Primary

MeasureTime frame
Change in Pain and Numbness Numeric Rating Scale (NRS) at the Final Measurement

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactSOICHIRO YUZURIHA

Tokai University Department of Urology

ys6683@tokai.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026