Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2022-03-18

Brief Summary

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This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate the efficacy of MC5-A scrambler therapy (scrambler therapy \[ST\]) in reducing chemotherapy-induced painful peripheral neuropathy (CIPPN).

II. Evaluate the change in pain score before and after 2 weeks (Monday-Friday) of the final ST treatment.

III. Assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (Monday-Friday) ST treatment.

SECONDARY OBJECTIVES:

I. To evaluate the following with the treatment of ST:

Ia. Assess for changes in therapy induced neuropathy assessment scale (TNAS). Ib. Assess for changes in using pain medications. Ic. Assess for changes in daily physical activities/functional status. Id. Assess for changes in quality of life using European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (chemotherapy induced peripheral neuropathy) chemotherapy-induced neuropathic pain (CIPN) 20 questionnaire.

Ie. Assess overall satisfaction with the ST treatment using Global Impression of Change questionnaire.

TERTIARY (EXPLORATORY) OBJECTIVE:

I. Determine the change in sensation after 2 weeks (Monday-Friday) of the final ST treatment.

OUTLINE:

Patients undergo scrambler therapy over 30-45 minutes once daily (QD) Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.

After completion of study, patients are followed up weekly for 3 weeks and at 4 weeks after the last day of scrambler therapy treatment.

Conditions

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Chemotherapy-Induced Peripheral Neuropathy Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (scrambler therapy, sensory test, gait test)

Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.

Group Type EXPERIMENTAL

FitBit

Intervention Type DEVICE

Wear FitBit for gait assessment test

Gait Assessment Test

Intervention Type OTHER

Undergo gait assessment test

MC5-A Scrambler Therapy

Intervention Type OTHER

Undergo scrambler therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Quantitative Sensory Testing

Intervention Type PROCEDURE

Undergo quantitative sensory test

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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FitBit

Wear FitBit for gait assessment test

Intervention Type DEVICE

Gait Assessment Test

Undergo gait assessment test

Intervention Type OTHER

MC5-A Scrambler Therapy

Undergo scrambler therapy

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Quantitative Sensory Testing

Undergo quantitative sensory test

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Scrambler Therapy Quality of Life Assessment QST

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy
* Have average pain intensity of at least 4/10
* Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment)
* Can give a written informed consent

Exclusion Criteria

* Pre-existence or history of seizure
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy
* Pregnancy
* Present with pacemaker or implantable defibrillators
* Present or past psychotropic substances and alcohol dependence
* Inability to understand patients' information and informed consent
* Skin lesion at the electrode placement site

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No