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Trial record 1 of 2 for:    CIPN | transcutaneous
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Testing the Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Chemotherapy-Induced Peripheral Neuropathy (CIPN)

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ClinicalTrials.gov Identifier: NCT04367480
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Device: Placebo Administration Other: Questionnaire Administration Device: Transcutaneous Electrical Nerve Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (TENS)
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Other: Questionnaire Administration
Ancillary studies

Device: Transcutaneous Electrical Nerve Stimulation
Wear active TENS device
Other Names:
  • TENS
  • transcutaneous electric nerve stimulation

Placebo Comparator: Group II (placebo TENS)
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Device: Placebo Administration
Wear placebo TENS device

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Chemotherapy-induced peripheral neuropathy (CIPN) symptoms [ Time Frame: After 6 weeks of device use ]
    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).


Secondary Outcome Measures :
  1. Effect of TENS on hot/burning and sharp/shooting pain [ Time Frame: At baseline and at week 6 ]
    Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning and sharp/shooting pain will be estimated using analysis of covariance (ANCOVA).

  2. Effect of TENS on numbness [ Time Frame: At baseline and at week 6 ]
    Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. he effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA).

  3. Effect of TENS on tingling [ Time Frame: At baseline and at 6 weeks ]
    Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. he effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA).

  4. Effect of TENS on cramping [ Time Frame: At baseline and 6 weeks ]
    Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. he effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA).


Other Outcome Measures:
  1. Effect of TENS on balance (on Short Physical Performance Battery [SPPB]) [ Time Frame: At baseline and 6 weeks ]
    Estimated using ANCOVA.

  2. Descending inhibition (on Conditioned Pain Modulation [CPM] test) [ Time Frame: At baseline and 6 weeks ]
    Estimated using ANCOVA. Descriptive statistics will be used to characterize the distribution of descending inhibition as measured by CPM at baseline. ANCOVA analysis will be used to investigate whether baseline descending inhibition predicts the effect of TENS on CIPN.

  3. Effect of TENS on physical function [ Time Frame: At baseline and 6 weeks ]
    Measured by Patient Reported Outcomes Measurement Information System (PROMIS) short form. 4 physical activity items are rated from 1-5 corresponding to "Cannot Do" to "Without any difficulty" and 4 items regarding how health limits activity are rated from 1-5 "Cannot Do" to "Not at all". Estimated using ANCOVA.

  4. CIPN-interference in daily life [ Time Frame: At baseline and 6 weeks ]
    Measured by the CIPN-interference in daily life questionnaire which uses 0-10 numeric rating scale [0 = does not interfere, 10 = completely interferes]. Estimated using ANCOVA.

  5. CIPN [ Time Frame: At baseline and 6 weeks ]
    Will be measured by Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory composite measure. The correlation of descending inhibition with CIPN severity (via CIPN20, TNAS, and symptom numeric rating scale [NRS] scores) will be evaluated using a Spearman's correlations. Estimated using ANCOVA.

  6. Depression and anxiety [ Time Frame: At baseline and 6 weeks ]
    Estimated using ANCOVA.

  7. Analgesic use [ Time Frame: At baseline and 6 weeks ]
    The proportion of participants who decreased "as-needed" usage of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) (defined as taking acetaminophen or NSAIDs, on average, at least 30% fewer days per week in the last week of the trial compared to the baseline week) will be compared by groups using a chi-square test.

  8. Patient reported change in CIPN symptoms [ Time Frame: At baseline and 6 weeks ]
    The proportion of participants who report, for the impression of change in CIPN symptoms question "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", and "very much worse") will be compared between treatment groups using a Cochran Armitage Trend Test.

  9. Patient sensation threshold from monofilament test [ Time Frame: At baseline and 6 weeks ]
    The proportion of participants whose sensation threshold from the monofilament test improved will be reported together with the 95% confidence interval (CI) and tested against the null hypothesis of no improvement.

  10. Percentage of participants and outcome assessors that correctly identify the group to which the participant was assigned [ Time Frame: After 6 weeks of device use ]
    Descriptive statistics and 95% CIs will be used to assess the percentage of participants and outcome assessors that correctly identify the group to which the participant was assigned as well as the basis for the guesses.

  11. Test, re-test reliability for CPM test [ Time Frame: After 6 weeks of device use ]
    Will be evaluated using intraclass correlation coefficients (ICCs). Test, re-test reliability for the lower limb sensation threshold test will be measured using Kappa statistics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367480


Contacts
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Contact: Cameron Coykendall 585-276-8311 URCC_19085@URMC.Rochester.edu

Locations
Show Show 22 study locations
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jennifer Gewandter University of Rochester NCORP Research Base
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Responsible Party: Gary Morrow, Director, URCC NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT04367480    
Other Study ID Numbers: URCC19085
NCI-2019-07566 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC19085 ( Other Identifier: University of Rochester NCORP Research Base )
URCC-19085 ( Other Identifier: DCP )
URCC-19085 ( Other Identifier: CTEP )
R21CA235389 ( U.S. NIH Grant/Contract )
UG1CA189961 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases