N/A N=36 Randomized Triple-blind Supportive Care

Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT02111174 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Change in Pain as Measured by the Modified Brief Pain Index at 28 Days — -0.5; -1.06 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Scrambler Therapy (Device); Sham Therapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain as Measured by the Modified Brief Pain Index at 28 Days	-0.5; -1.06	—
SECONDARY Change in Pain at 2 Months as Measured by the Modified Brief Pain Index	-0.31; -0.25	—
SECONDARY Change in Pain at 3 Months as Measured by the Modified Brief Pain Index	-0.75; -0.44	—
SECONDARY Changes in Patient Reported Sensory Outcomes at 28 Days	-4.76; -4.67	—
SECONDARY Changes in Patient Reported Sensory Outcomes at 2 Months	-8.94; -8.39	—
SECONDARY Changes in Patient Reported Sensory Outcomes at 3 Months	-9.62; -11.39	—
SECONDARY Changes in Patient Reported Motor Outcomes at 28 Days	-2.97; -2.83	—
SECONDARY Changes in Patient Reported Motor Outcomes at 2 Months	-5.88; -5.67	—
SECONDARY Changes in Patient Reported Motor Outcomes at 3 Months	-6.62; -8.53	—
SECONDARY Number of Patients Who Stopped Using Opioids at 28 Days	3; 1	—
SECONDARY Number of Patients Who Stopped Using Neuroleptics at 28 Days	1; 0	—

Summary

The purpose of this study is to see if Scrambler Therapy with the Calmare MC5-A machine will relieve chemotherapy induced peripheral neuropathy (CIPN). Scrambler Therapy is a method of pain relief given with common electrocardiography (ECG) skin electrodes. The electrodes are placed on the body in pairs, and the Scrambler Therapy machine directs electrical signals across the field to simulate non-pain information. Based on other studies, we think that we relieve pain with the Scrambler therapy device, but it has not been tested in a setting such as this one. This means that some of the pain relief could be due to placebo effect, or the CIPN pain going away on its own. In this study we want to compare the Scrambler Therapy with the sham therapy (the therapy that does not use the electrical signals). We hope that this study will help us determine if the Scrambler device really helps patients with CIPN. Cancer patients with chronic, chemotherapy-related pain of 4 or more (on a 0-10 scale) for at least 3 months may be eligible to join this study.

Eligibility Criteria

Inclusion Criteria

Men and women, 18 years of age or older with cancer
English speakers
Lower extremity CIPN neuropathy: Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezimib).
Pain or symptoms of lower extremity peripheral neuropathy of >3 month's duration attributed to chemotherapy-induced peripheral neuropathy
An average daily pain rating of > 4 out of 10
Life expectancy >3 months
ECOG Performance Status 0, 1, 2, or 3
Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

Exclusion Criteria

Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, abstinence, etc.).
Use of an investigational agent for pain control concurrently or within the past 30 days
History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
Patients with a history of myocardial infarction or ischemic heart disease within the past six months
Patients with history of epilepsy, brain damage, or symptomatic brain metastases
Prior celiac plexus block, or other neurolytic pain control treatment
Other identified causes of painful parasthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: e.g., carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient's current neuropathic symptoms
Skin conditions such as open sores that would prevent proper application of the electrodes
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Currently receiving anti-convulsants (such as gabapentinoids, e.g. gabapentin (Neurontin) or pregabalin (Lyrica). Because of data that support that patients do not do as well when on gabapentin or pregabalin, all patients on these medications will be weaned off them prior to study initiation. The study team will provide instructions on how to do this

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Data sourced from ClinicalTrials.gov (NCT02111174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.