Clinical trial NCT02111174: Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
Official title: A Pilot Randomized Sham-Controlled Trial of MC5-A Calmare Therapy (Scrambler Therapy) in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy
Keywords: Neuropathy
Peripheral neuropathy
Chemotherapy-induced peripheral neuropathy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Change in Pain as Measured by the Modified Brief Pain Index at 28 Days
timeFrame: Change from baseline to 28 days
Secondary outcomes:
measure: Change in Pain at 2 Months as Measured by the Modified Brief Pain Index
timeFrame: Change from baseline to 2 months
measure: Change in Pain at 3 Months as Measured by the Modified Brief Pain Index
timeFrame: Change from baseline to 3 months
measure: Changes in Patient Reported Sensory Outcomes at 28 Days
timeFrame: Change from baseline to 28 days
measure: Changes in Patient Reported Sensory Outcomes at 2 Months
timeFrame: Change from baseline to 2 months
measure: Changes in Patient Reported Sensory Outcomes at 3 Months
timeFrame: Change from baseline to 3 months
measure: Changes in Patient Reported Motor Outcomes at 28 Days
timeFrame: Change from baseline to 28 days
measure: Changes in Patient Reported Motor Outcomes at 2 Months
timeFrame: Change from baseline to 2 months
measure: Changes in Patient Reported Motor Outcomes at 3 Months
timeFrame: Change from baseline to 3 months
measure: Number of Patients Who Stopped Using Opioids at 28 Days
timeFrame: 28 days post-intervention
measure: Number of Patients Who Stopped Using Neuroleptics at 28 Days
timeFrame: 28 days post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: SKCCC at Johns Hopkins
name: Thomas J. Smith, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cathcart-Rake EJ, Hilliker DR, Loprinzi CL. Chemotherapy-induced neuropathy: Central resolution of a peripherally perceived problem? Cancer. 2017 Jun 1;123(11):1898-1900. doi: 10.1002/cncr.30650. Epub 2017 Mar 3. No abstract available.