Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Peripheral Neuropathy; Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: FitBit; Other: Gait Assessment Test; Other: MC5-A Scrambler Therapy; Procedure: Quantitative Sensory Testing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: FitBit; Wear FitBit for gait assessment test; Other: Gait Assessment Test; Undergo gait assessment test; Other: MC5-A Scrambler Therapy; Undergo scrambler therapy; Other Names: Scrambler Therapy; Procedure: Quantitative Sensory Testing; Undergo quantitative sensory test; Other Names: QST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemotherapy induced peripheral neuropathic pain (CIPN) score difference	Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).	Baseline to the last day of 2-week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in therapy-induced neuropathy	Will be assessed using therapy induced neuropathy assessment scale. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate.	Baseline to the last day of 2-week treatment
Change in cancer-related symptoms	Will be assessed using therapy induced neuropathy assessment scale. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate.	Baseline to the last day of 2-week treatment
Change in physical function and quality of life	Will be assessed using the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire CIPN20 questionnaire. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).	Baseline to the last day of 2-week treatment

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Salahadin Abdi, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Neoplasms; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2018-0651 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2019-08323 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No