# Wireless transcutaneous electrical stimulation (TENS) for chemotherapy-induced peripheral neuropathy: A phase II randomized clinical trial

> **NIH NIH R21** · UNIVERSITY OF ROCHESTER · 2020 · $171,297

## Abstract

PROJECT SUMMARY
Chemotherapy-induced peripheral neuropathy (CIPN) occurs in approximately 60% of patients who
receive neurotoxic chemotherapy agents. Symptoms of CIPN include burning/shooting pain, tingling,
cramping, and numbness in the hands and feet. CIPN is associated with impaired balance, walking,
and sleep, decreased quality of life, and falls. Few, only minimally effective treatments are available for
CIPN; these pharmacologic treatments are rarely evidenced-based, potentially addictive, and
contribute to polypharmacy. Some research suggests that CIPN results from abnormal neuronal
processing in the central and peripheral nervous systems, including decreased central descending
inhibitory mechanisms. Data suggests that transcutaneous electrical nerve stimulation (TENS) relieves
symptoms in other neuropathic pain conditions, partly by activating central descending inhibitory
pathways, but this mechanism has yet to be investigated for TENS in CIPN. The proposed research
aims to investigate the preliminary efficacy of TENS, a safe, inexpensive, non-pharmacologic treatment
for CIPN. A rigorous phase II, multi-site, patient- and assessor-blinded randomized clinical trial (RCT)
that investigates physiologic and psychologic mechanisms and leverages the NCI Community
Oncology Research Program (NCORP) for efficiency is proposed. The purpose of the study is to obtain
data to inform the conduct of a confirmatory, phase III RCT. The proposed TENS device is a patient-
controlled, wireless unit that can conveniently be worn throughout the day during physical activity; the
unit is ideal for maximizing adherence in clinical trials and for optimizing dissemination in clinical
practice. The primary aim of the study is to obtain preliminary efficacy estimates (effect sizes and
confidence intervals) of TENS on a composite measure of CIPN (CIPN20). Secondary aims include
obtaining (1) preliminary efficacy estimates for individual CIPN symptoms (0 – 10 numeric rating
scales), (2) preliminary efficacy of TENS on activity and balance in patients with CIPN, (3) effects of
TENS on central descending inhibitory mechanisms in CIPN patients, and (4) feasibility data for
conducting a patient- and assessor-blinded RCT of TENS in the multi-site NCORP Research Network.
This phase II RCT is an integral step in a program of research that will rigorously evaluate the efficacy
of TENS for CIPN. Establishing effective, non-pharmacologic treatments for CIPN will help to mitigate
suffering in cancer survivors while avoiding potentially harmful side effects caused by many currently
available analgesic drugs.

## Key facts

- **NIH application ID:** 9994259
- **Project number:** 5R21CA235389-02
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Jennifer Gewandter
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $171,297
- **Award type:** 5
- **Project period:** 2019-08-12 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994259

## Citation

> US National Institutes of Health, RePORTER application 9994259, Wireless transcutaneous electrical stimulation (TENS) for chemotherapy-induced peripheral neuropathy: A phase II randomized clinical trial (5R21CA235389-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9994259. Licensed CC0.

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