Clinical trial NCT04367480: Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy
Official title: Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-29
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Have completed treatment with a platinum agent, taxane, vinca alkaloid, or bortezomib at least 3 months prior to registration
* Have a clinical diagnosis of CIPN from their physician or physician designee based on the following criteria: bilateral (i.e., present on both sides of the body), abnormal sensory symptoms in their feet or legs (e.g., hot/burning pain, sharp/shooting pain, numbness, tingling, cramping)
* Report at least 1 non-painful symptom associated with CIPN in their lower limbs (e.g., tingling, burning that isn't reported as painful, numbness)
* Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
* Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen \[Tylenol\] or non-steroidal anti-inflammatory drugs \[NSAIDs\] \[i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)\]) for the duration of the study
* Be able to read English (i.e., is not illiterate, can speak English, and is not blind)
* Have access to a smart phone or device with an Apple or Android operating system that can be used to access the TENS device's application (App) and ability to connect to the internet on a daily basis during the trial

Exclusion Criteria:

* Have pre-existing neuropathy of any cause documented in their medical record prior to the start of chemotherapy or respond "yes" to the question "Did you have frequent numbness, tingling, sharp/shooting pain, hot/burning pain, or cramping in your feet before you started your chemotherapy?"
* Have unilateral CIPN symptoms (i.e., symptoms occur on predominantly only one side of the body)
* Be currently using a TENS device for any other reason
* Be currently taking, or have taken in the past 3 months, medications known to cause neuropathy in a significant portion of patients
* Have an acute and symptomatic lower extremity deep vein thrombosis (DVT) (treated DVT with resolution of symptoms is acceptable for enrollment)
* Lower extremity edema that is 2+ or greater (i.e., slight indentation that takes less than 15 seconds to rebound)
* Have started a new prescription pain medication or altered dosages of a prescription pain medication within the last 2 weeks
* Have lower extremity wounds or ulcers
* Have a cardiac pace maker or defibrillator
* Have epilepsy
* Have a leg that is too small or too large for the TENS device to fit securely
* Have missing lower limbs or amputations
* Have impaired decision making capacity (i.e., requires a legally authorized representative or health care proxy)
* Be pregnant or planning to get pregnant before expected completion of the study

Primary outcomes:
measure: Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
timeFrame: 6 weeks after the start of intervention
Secondary outcomes:
measure: Effect of TENS on Hot/Burning Pain
timeFrame: 6 weeks after the start of intervention
measure: Effect of TENS on Sharp/Shooting Pain
timeFrame: 6 weeks after the start of intervention
measure: Effect of TENS on Numbness
timeFrame: 6 weeks after the start of intervention
measure: Effect of TENS on Tingling
timeFrame: 6 weeks after the start of intervention
measure: Effect of TENS on Cramping
timeFrame: 6 weeks after the start of intervention
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Health Care System
state: Delaware
city: Fort Myers
country: United States
facility: Lee Memorial Health System
state: Florida
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Gaffney
country: United States
facility: Gibbs Cancer Center-Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Gibbs Cancer Center-Pelham
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Union
country: United States
facility: MGC Hematology Oncology-Union
state: South Carolina
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital Cancer Center at St. Mary's
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Jennifer Gewandter
role: PRINCIPAL_INVESTIGATOR
References: