NCT04367480

Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 \[EORTC-CIPN20\]) to inform the design of a phase III confirmatory trial. SECONDARY OBJECTIVES: I. Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale \[NRS\]). II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation \[CPM\] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test. EXPLORATORY OBJECTIVES: I. Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression. II. Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. GROUP II: Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Placebo Administration	Wear placebo TENS device
OTHER	Questionnaire Administration	Ancillary studies
DEVICE	Transcutaneous Electrical Nerve Stimulation	Wear active TENS device

Timeline

• Start date: 2020-09-10
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2020-04-29
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study