CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Placebo Administration +2 moredevice
Likely dose
Wireless TENS device (specific dose/frequency not specified in published record)AI-extracted
Key inclusion· 6
  • Completed platinum agent, taxane, vinca alkaloid, or bortezomib therapy at least 3 months prior to registration
  • Clinical diagnosis of bilateral CIPN with abnormal sensory symptoms in feet or legs (pain, numbness, tingling, cramping)
  • At least 1 non-painful CIPN symptom in lower limbs (tingling, burning, or numbness)
  • At least 2 symptoms in lower limbs rated ≥4/10 on 0-10 scale (hot/burning pain, sharp/shooting pain, numbness, tingling, or cramping)
Key exclusion· 10
  • Pre-existing neuropathy of any cause prior to chemotherapy or history of numbness, tingling, or neuropathic pain before chemotherapy
  • Unilateral CIPN symptoms (symptoms on predominantly only one side of body)
  • Currently using TENS device for any other reason
  • Currently taking or taken in past 3 months medications known to cause neuropathy in significant portion of patients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04367480
NCT04367480N/ACompleted

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial

University of Rochester NCORP Research Base·interventional·Posted Apr 29, 2020·Updated Sep 8, 2023

In Brief

A clinical study evaluating Placebo Administration, Questionnaire Administration, and 1 other intervention for Chemotherapy-Induced Peripheral Neuropathy. Completed, enrolled 151 participants across 15 sites.

Detailed Summary

This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 29, 2020
Enrollment StartSep 10, 2020
Primary CompletionOct 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.2 years ago

Interventions

Placebo Administrationdevice

Wear placebo TENS device

Questionnaire Administrationother

Ancillary studies

Transcutaneous Electrical Nerve Stimulationdevice

Wear active TENS device