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Completed

NCT Number: NCT04239976

Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

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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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit

Device

Wear FitBit for gait assessment test

Gait Assessment Test

Other

Undergo gait assessment test

MC5-A Scrambler Therapy

Other

Undergo scrambler therapy

Other names: Scrambler Therapy

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Quantitative sensory testing

Procedure

Undergo quantitative sensory test

Other names: QST

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Chemotherapy induced peripheral neuropathic pain (CIPN) score difference

    Time frame: Baseline to the last day of 2-week treatment

    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).

Secondary outcomes

  1. Change in therapy-induced neuropathy

    Time frame: Baseline to the last day of 2-week treatment

    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.

  2. Change in cancer-related symptoms

    Time frame: Baseline to the last day of 2-week treatment

    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.

  3. Change in physical function and quality of life

    Time frame: Baseline to the last day of 2-week treatment

    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).

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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