Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Neurology, Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/19/2018 |
| Start Date: | March 2015 |
| End Date: | March 24, 2017 |
A Pilot Randomized Sham-Controlled Trial of MC5-A Calmare Therapy (Scrambler Therapy) in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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.
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.
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
We found this trial at
1
site
Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Thomas J. Smith, MD, FACP
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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