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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
151
Christiana Health Care System
Newark, Delaware, United States
Lee Memorial Health System
Fort Myers, Florida, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
...and 5 more locations
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy
Time frame: 6 weeks after the start of intervention
Effect of TENS on Hot/Burning Pain
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22).
Time frame: 6 weeks after the start of intervention
Effect of TENS on Sharp/Shooting Pain
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on sharp/shooting pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)
Time frame: 6 weeks after the start of intervention
Effect of TENS on Numbness
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)
Time frame: 6 weeks after the start of intervention
Effect of TENS on Tingling
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)
Time frame: 6 weeks after the start of intervention
Effect of TENS on Cramping
Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)
Time frame: 6 weeks after the start of intervention
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