Chemotherapy-Induced Peripheral Neuropathy
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Change in Pain and Numbness Numeric Rating Scale (NRS) at the Final Measurement | — |
Secondary
| Measure | Time 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
Tokai University Department of Urology