Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

M.D. Anderson Cancer Center

Status: Completed

Conditions: Malignant Neoplasm; Chemotherapy-Induced Peripheral Neuropathy

Treatments: Procedure: Quantitative Sensory Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Gait Assessment Test; Device: FitBit; Other: MC5-A Scrambler Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04239976

P30CA016672 (U.S. NIH Grant/Contract)

2018-0651 (Other Identifier)

NCI-2019-08323 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Other: MC5-A Scrambler Therapy

Device: FitBit

Other: Gait Assessment Test

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Quantitative Sensory Testing