Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239976
• Other study ID #: 2018-0651
• Secondary ID: NCI-2019-0832320
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Malignant Neoplasm
• Neoplasms
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Device:
• FitBit
Wear FitBit for gait assessment test

Other:
• Gait Assessment Test
Undergo gait assessment test
• MC5-A Scrambler Therapy
Undergo scrambler therapy
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Quantitative Sensory Testing
Undergo quantitative sensory test

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center Website