Clinical trial NCT04239976: Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain
Official title: Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
timeFrame: Baseline to the last day of 2-week treatment
Secondary outcomes:
measure: Change in therapy-induced neuropathy
timeFrame: Baseline to the last day of 2-week treatment
measure: Change in cancer-related symptoms
timeFrame: Baseline to the last day of 2-week treatment
measure: Change in physical function and quality of life
timeFrame: Baseline to the last day of 2-week treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Salahadin Abdi
role: PRINCIPAL_INVESTIGATOR
References: